Flow diverters
Pipeline
A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.
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Where to buy Pipeline
Contact Micro Therapeutics, Inc. directly; they can quote, ship, or point you to the distributor for your country.
From lavascular.com, checked October 2026.
No reply, or outside their markets? Send us a request and we route it to a rep or distributor for your country.
Pipeline models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| FA-71300-25 | Outer Diameter 3.0 mm; Length 25.0 mm | MR Conditional | Available |
| FA-71300-25 | β | MR Conditional | Available |
| FA-71300-25 | Length 25 mm; Outer Diameter 3.00 mm | MR Conditional | Available |
| FA-71300-30 | β | MR Conditional | Available |
| FA-71300-30 | Length 30 mm; Outer Diameter 3.00 mm | MR Conditional | Available |
| FA-71300-35 | Outer Diameter 3.0 mm; Length 35.0 mm | MR Conditional | Available |
| FA-71300-35 | Length 35 mm; Outer Diameter 3.00 mm | MR Conditional | Available |
| FA-71325-25 | β | MR Conditional | Available |
| FA-71325-25 | Length 25.0 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-71325-25 | Length 25 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-71325-30 | Length 30 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-71325-30 | Length 30.0 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-71325-35 | Length 35.0 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-71325-35 | β | MR Conditional | Available |
| FA-71350-25 | β | MR Conditional | Available |
| FA-71350-25 | Outer Diameter 3.5 mm; Length 25.0 mm | MR Conditional | Available |
| FA-71350-30 | β | MR Conditional | Available |
| FA-71350-30 | Length 30 mm; Outer Diameter 3.50 mm | MR Conditional | Available |
| FA-71350-30 | Length 30.0 mm; Outer Diameter 3.5 mm | MR Conditional | Available |
| FA-71350-35 | Length 35.0 mm; Outer Diameter 3.5 mm | MR Conditional | Available |
| FA-71350-35 | β | MR Conditional | Available |
| FA-71350-35 | Length 35 mm; Outer Diameter 3.50 mm | MR Conditional | Available |
| FA-71375-25 | β | MR Conditional | Available |
| FA-71375-25 | Length 25.0 mm; Outer Diameter 3.75 mm | MR Conditional | Available |
| FA-71375-25 | Length 25 mm; Outer Diameter 3.75 mm | MR Conditional | Available |
| FA-71375-30 | Length 30 mm; Outer Diameter 3.75 mm | MR Conditional | Available |
| FA-71375-30 | Length 30.0 mm; Outer Diameter 3.75 mm | MR Conditional | Available |
| FA-71375-30 | β | MR Conditional | Available |
| FA-71375-35 | β | MR Conditional | Available |
| FA-71375-35 | Length 35.0 mm; Outer Diameter 3.75 mm | MR Conditional | Available |
| FA-71400-25 | Length 25 mm; Outer Diameter 4.00 mm | MR Conditional | Available |
| FA-71400-25 | Length 25.0 mm; Outer Diameter 4.0 mm | MR Conditional | Available |
| FA-71400-25 | β | MR Conditional | Available |
| FA-71400-30 | β | MR Conditional | Available |
| FA-71400-30 | Length 30 mm; Outer Diameter 4.00 mm | MR Conditional | Available |
| FA-71400-30 | Length 30.0 mm; Outer Diameter 4.0 mm | MR Conditional | Available |
| FA-71400-35 | Length 35 mm; Outer Diameter 4.00 mm | MR Conditional | Available |
| FA-71400-35 | Length 35.0 mm; Outer Diameter 4.0 mm | MR Conditional | Available |
| FA-71400-35 | β | MR Conditional | Available |
| FA-71425-25 | Outer Diameter 4.25 mm; Length 25.0 mm | MR Conditional | Available |
| FA-71425-25 | Length 25 mm; Outer Diameter 4.25 mm | MR Conditional | Available |
| FA-71425-30 | Outer Diameter 4.25 mm; Length 30.0 mm | MR Conditional | Available |
| FA-71425-30 | Length 30 mm; Outer Diameter 4.25 mm | MR Conditional | Available |
| FA-71425-35 | β | MR Conditional | Available |
| FA-71425-35 | Length 35 mm; Outer Diameter 4.25 mm | MR Conditional | Available |
| FA-71425-35 | Outer Diameter 4.25 mm; Length 35.0 mm | MR Conditional | Available |
| FA-71450-25 | Length 25 mm; Outer Diameter 4.50 mm | MR Conditional | Available |
| FA-71450-25 | Length 25.0 mm; Outer Diameter 4.5 mm | MR Conditional | Available |
| FA-71450-30 | Length 30.0 mm; Outer Diameter 4.5 mm | MR Conditional | Available |
| FA-71450-30 | Length 30 mm; Outer Diameter 4.50 mm | MR Conditional | Available |
| FA-71450-30 | β | MR Conditional | Available |
| FA-71450-35 | Length 35.0 mm; Outer Diameter 4.5 mm | MR Conditional | Available |
| FA-71450-35 | Length 35 mm; Outer Diameter 4.50 mm | MR Conditional | Available |
| FA-71450-35 | β | MR Conditional | Available |
| FA-71475-25 | Outer Diameter 4.75 mm; Length 25.0 mm | MR Conditional | Available |
| FA-71475-30 | β | MR Conditional | Available |
| FA-71475-30 | Length 30 mm; Outer Diameter 4.75 mm | MR Conditional | Available |
| FA-71475-30 | Length 30.0 mm; Outer Diameter 4.75 mm | MR Conditional | Available |
| FA-71475-35 | Length 35 mm; Outer Diameter 4.75 mm | MR Conditional | Available |
| FA-71475-35 | Length 35.0 mm; Outer Diameter 4.75 mm | MR Conditional | Available |
| FA-71475-35 | β | MR Conditional | Available |
| FA-71500-25 | β | MR Conditional | Available |
| FA-71500-25 | Length 25 mm; Outer Diameter 5.00 mm | MR Conditional | Available |
| FA-71500-25 | Length 25.0 mm; Outer Diameter 5.0 mm | MR Conditional | Available |
| FA-71500-30 | β | MR Conditional | Available |
| FA-71500-30 | Length 30 mm; Outer Diameter 5.00 mm | MR Conditional | Available |
| FA-71500-30 | Outer Diameter 5.0 mm; Length 30.0 mm | MR Conditional | Available |
| FA-71500-35 | β | MR Conditional | Available |
| FA-71500-35 | Length 35 mm; Outer Diameter 5.00 mm | MR Conditional | Available |
| FA-71500-35 | Outer Diameter 5.0 mm; Length 35.0 mm | MR Conditional | Available |
| FA-77250-10 | β | MR Conditional | Available |
| FA-77250-12 | β | MR Conditional | Available |
| FA-77250-12 | Length 12 mm; Outer Diameter 2.50 mm | MR Conditional | Available |
| FA-77250-14 | β | MR Conditional | Available |
| FA-77250-14 | Length 14 mm; Outer Diameter 2.50 mm | MR Conditional | Available |
| FA-77250-14 | Outer Diameter 2.5 mm; Length 14.0 mm | MR Conditional | Available |
| FA-77250-16 | Outer Diameter 2.5 mm; Length 16.0 mm | MR Conditional | Available |
| FA-77250-16 | Length 16 mm; Outer Diameter 2.50 mm | MR Conditional | Available |
| FA-77250-16 | β | MR Conditional | Available |
| FA-77250-18 | β | MR Conditional | Available |
| FA-77250-18 | Outer Diameter 2.5 mm; Length 18.0 mm | MR Conditional | Available |
| FA-77250-18 | Length 18 mm; Outer Diameter 2.50 mm | MR Conditional | Available |
| FA-77250-20 | Length 20 mm; Outer Diameter 2.50 mm | MR Conditional | Available |
| FA-77250-20 | β | MR Conditional | Available |
| FA-77275-10 | Length 10 mm; Outer Diameter 2.75 mm | MR Conditional | Available |
| FA-77275-10 | Length 10.0 mm; Outer Diameter 2.75 mm | MR Conditional | Available |
| FA-77275-10 | β | MR Conditional | Available |
| FA-77275-12 | β | MR Conditional | Available |
| FA-77275-12 | Length 12 mm; Outer Diameter 2.75 mm | MR Conditional | Available |
| FA-77275-12 | Outer Diameter 2.75 mm; Length 12.0 mm | MR Conditional | Available |
| FA-77275-14 | β | MR Conditional | Available |
| FA-77275-14 | Length 14 mm; Outer Diameter 2.75 mm | MR Conditional | Available |
| FA-77275-14 | Length 14.0 mm; Outer Diameter 2.75 mm | MR Conditional | Available |
| FA-77275-16 | Length 16.0 mm; Outer Diameter 2.75 mm | MR Conditional | Available |
| FA-77275-16 | β | MR Conditional | Available |
| FA-77275-16 | Length 16 mm; Outer Diameter 2.75 mm | MR Conditional | Available |
| FA-77275-18 | Length 18 mm; Outer Diameter 2.75 mm | MR Conditional | Available |
| FA-77275-18 | β | MR Conditional | Available |
| FA-77275-18 | Length 18.0 mm; Outer Diameter 2.75 mm | MR Conditional | Available |
| FA-77275-20 | β | MR Conditional | Available |
| FA-77275-20 | Length 20.0 mm; Outer Diameter 2.75 mm | MR Conditional | Available |
| FA-77275-20 | Length 20 mm; Outer Diameter 2.75 mm | MR Conditional | Available |
| FA-77300-10 | Outer Diameter 3.0 mm; Length 10.0 mm | MR Conditional | Available |
| FA-77300-10 | Length 10 mm; Outer Diameter 3.00 mm | MR Conditional | Available |
| FA-77300-10 | β | MR Conditional | Available |
| FA-77300-12 | Length 12.0 mm; Outer Diameter 3.0 mm | MR Conditional | Available |
| FA-77300-12 | Length 12 mm; Outer Diameter 3.00 mm | MR Conditional | Available |
| FA-77300-14 | β | MR Conditional | Available |
| FA-77300-14 | Length 14 mm; Outer Diameter 3.00 mm | MR Conditional | Available |
| FA-77300-16 | β | MR Conditional | Available |
| FA-77300-16 | Length 16 mm; Outer Diameter 3 mm | MR Conditional | Available |
| FA-77300-16 | Outer Diameter 3.0 mm; Length 16.0 mm | MR Conditional | Available |
| FA-77300-18 | β | MR Conditional | Available |
| FA-77300-18 | Length 18.0 mm; Outer Diameter 3.0 mm | MR Conditional | Available |
| FA-77300-18 | Length 18 mm; Outer Diameter 3 mm | MR Conditional | Available |
| FA-77300-20 | β | MR Conditional | Available |
| FA-77300-20 | Length 20.0 mm; Outer Diameter 3.0 mm | MR Conditional | Available |
| FA-77300-20 | Length 20 mm; Outer Diameter 3 mm | MR Conditional | Available |
| FA-77325-10 | Length 10.0 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-77325-10 | Length 10 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-77325-10 | β | MR Conditional | Available |
| FA-77325-12 | Length 12.0 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-77325-12 | β | MR Conditional | Available |
| FA-77325-12 | Length 12 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-77325-14 | Length 14 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-77325-14 | β | MR Conditional | Available |
| FA-77325-14 | Length 14.0 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-77325-16 | β | MR Conditional | Available |
| FA-77325-16 | Outer Diameter 3.25 mm; Length 16.0 mm | MR Conditional | Available |
| FA-77325-16 | Length 16 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-77325-18 | β | MR Conditional | Available |
| FA-77325-18 | Length 18.0 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-77325-18 | Length 18 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-77325-20 | β | MR Conditional | Available |
| FA-77325-20 | β | MR Conditional | Available |
| FA-77325-20 | Length 20 mm; Outer Diameter 3.25 mm | MR Conditional | Available |
| FA-77350-10 | Length 10 mm; Outer Diameter 3.5 mm | MR Conditional | Available |
| FA-77350-10 | β | MR Conditional | Available |
| FA-77350-10 | β | MR Conditional | Available |
| FA-77350-12 | β | MR Conditional | Available |
| FA-77350-12 | β | MR Conditional | Available |
| FA-77350-12 | Length 12 mm; Outer Diameter 3.5 mm | MR Conditional | Available |
| FA-77350-14 | β | MR Conditional | Available |
| FA-77350-14 | β | MR Conditional | Available |
| FA-77350-14 | Length 14 mm; Outer Diameter 3.5 mm | MR Conditional | Available |
| FA-77350-16 | β | MR Conditional | Available |
| FA-77350-16 | β | MR Conditional | Available |
| FA-77350-16 | Length 16 mm; Outer Diameter 3.5 mm | MR Conditional | Available |
| FA-77350-18 | β | MR Conditional | Available |
| FA-77350-18 | Length 18 mm; Outer Diameter 3.5 mm | MR Conditional | Available |
| FA-77350-18 | β | MR Conditional | Available |
| FA-77350-20 | β | MR Conditional | Available |
| FA-77350-20 | Length 20 mm; Outer Diameter 3.5 mm | MR Conditional | Available |
| FA-77375-10 | β | MR Conditional | Available |
| FA-77375-10 | β | MR Conditional | Available |
| FA-77375-12 | β | MR Conditional | Available |
| FA-77375-12 | β | MR Conditional | Available |
| FA-77375-14 | β | MR Conditional | Available |
| FA-77375-14 | Length 14 mm; Outer Diameter 3.75 mm | MR Conditional | Available |
| FA-77375-16 | Length 16 mm; Outer Diameter 3.75 mm | MR Conditional | Available |
| FA-77375-16 | β | MR Conditional | Available |
| FA-77375-16 | β | MR Conditional | Available |
| FA-77375-18 | β | MR Conditional | Available |
| FA-77375-18 | β | MR Conditional | Available |
| FA-77375-20 | β | MR Conditional | Available |
| FA-77375-20 | β | MR Conditional | Available |
| FA-77400-10 | Length 10 mm; Outer Diameter 4 mm | MR Conditional | Available |
| FA-77400-10 | β | MR Conditional | Available |
| FA-77400-10 | Outer Diameter 4.0 mm; Length 10.0 mm | MR Conditional | Available |
| FA-77400-12 | Length 12 mm; Outer Diameter 4 mm | MR Conditional | Available |
| FA-77400-12 | β | MR Conditional | Available |
| FA-77400-12 | Length 12.0 mm; Outer Diameter 4.0 mm | MR Conditional | Available |
| FA-77400-14 | β | MR Conditional | Available |
| FA-77400-14 | Length 14 mm; Outer Diameter 4 mm | MR Conditional | Available |
| FA-77400-14 | Length 14.0 mm; Outer Diameter 4.0 mm | MR Conditional | Available |
| FA-77400-16 | Length 16 mm; Outer Diameter 4 mm | MR Conditional | Available |
| FA-77400-16 | Outer Diameter 4.0 mm; Length 16.0 mm | MR Conditional | Available |
| FA-77400-18 | Length 18 mm; Outer Diameter 4 mm | MR Conditional | Available |
| FA-77400-18 | β | MR Conditional | Available |
| FA-77400-18 | Outer Diameter 4.0 mm; Length 18.0 mm | MR Conditional | Available |
| FA-77400-20 | Length 20 mm; Outer Diameter 4 mm | MR Conditional | Available |
| FA-77400-20 | β | MR Conditional | Available |
| FA-77400-20 | Length 20.0 mm; Outer Diameter 4.0 mm | MR Conditional | Available |
| FA-77425-10 | Length 10.0 mm; Outer Diameter 4.25 mm | MR Conditional | Available |
| FA-77425-10 | β | MR Conditional | Available |
| FA-77425-12 | β | MR Conditional | Available |
| FA-77425-12 | Length 12 mm; Outer Diameter 4.25 mm | MR Conditional | Available |
| FA-77425-14 | Length 14.0 mm; Outer Diameter 4.25 mm | MR Conditional | Available |
| FA-77425-14 | Length 14 mm; Outer Diameter 4.25 mm | MR Conditional | Available |
| FA-77425-16 | Length 16 mm; Outer Diameter 4.25 mm | MR Conditional | Available |
| FA-77425-16 | β | MR Conditional | Available |
| FA-77425-16 | Length 16.0 mm; Outer Diameter 4.25 mm | MR Conditional | Available |
| FA-77425-18 | Length 18 mm; Outer Diameter 4.25 mm | MR Conditional | Available |
| FA-77425-18 | Outer Diameter 4.25 mm; Length 18.0 mm | MR Conditional | Available |
| FA-77425-18 | β | MR Conditional | Available |
| FA-77425-20 | Length 20 mm; Outer Diameter 4.25 mm | MR Conditional | Available |
| FA-77425-20 | Length 20.0 mm; Outer Diameter 4.25 mm | MR Conditional | Available |
| FA-77450-10 | β | MR Conditional | Available |
| FA-77450-10 | Outer Diameter 4.5 mm; Length 10.0 mm | MR Conditional | Available |
| FA-77450-10 | Length 10 mm; Outer Diameter 4.5 mm | MR Conditional | Available |
| FA-77450-12 | β | MR Conditional | Available |
| FA-77450-12 | Outer Diameter 4.5 mm; Length 12.0 mm | MR Conditional | Available |
| FA-77450-12 | Length 12 mm; Outer Diameter 4.5 mm | MR Conditional | Available |
| FA-77450-14 | Length 14 mm; Outer Diameter 4.5 mm | MR Conditional | Available |
| FA-77450-14 | Outer Diameter 4.5 mm; Length 14.0 mm | MR Conditional | Available |
| FA-77450-14 | β | MR Conditional | Available |
| FA-77450-16 | β | MR Conditional | Available |
| FA-77450-16 | Length 16 mm; Outer Diameter 4.5 mm | MR Conditional | Available |
| FA-77450-16 | Length 16.0 mm; Outer Diameter 4.5 mm | MR Conditional | Available |
| FA-77450-18 | β | MR Conditional | Available |
| FA-77450-18 | Outer Diameter 4.5 mm; Length 18.0 mm | MR Conditional | Available |
| FA-77450-20 | β | MR Conditional | Available |
| FA-77450-20 | Length 20.0 mm; Outer Diameter 4.5 mm | MR Conditional | Available |
| FA-77450-20 | Length 20 mm; Outer Diameter 4.5 mm | MR Conditional | Available |
| FA-77475-10 | Length 10.0 mm; Outer Diameter 4.75 mm | MR Conditional | Available |
| FA-77475-10 | Length 10 mm; Outer Diameter 4.75 mm | MR Conditional | Available |
| FA-77475-10 | β | MR Conditional | Available |
| FA-77475-12 | β | MR Conditional | Available |
| FA-77475-12 | Outer Diameter 4.75 mm; Length 12.0 mm | MR Conditional | Available |
| FA-77475-12 | Length 12 mm; Outer Diameter 4.75 mm | MR Conditional | Available |
| FA-77475-14 | β | MR Conditional | Available |
| FA-77475-14 | Length 14.0 mm; Outer Diameter 4.75 mm | MR Conditional | Available |
| FA-77475-16 | Length 16.0 mm; Outer Diameter 4.75 mm | MR Conditional | Available |
| FA-77475-16 | Length 16 mm; Outer Diameter 4.75 mm | MR Conditional | Available |
| FA-77475-18 | Outer Diameter 4.75 mm; Length 18.0 mm | MR Conditional | Available |
| FA-77475-18 | β | MR Conditional | Available |
| FA-77475-20 | β | MR Conditional | Available |
| FA-77475-20 | Length 20 mm; Outer Diameter 4.75 mm | MR Conditional | Available |
| FA-77475-20 | Outer Diameter 4.75 mm; Length 20.0 mm | MR Conditional | Available |
| FA-77500-12 | Length 12 mm; Outer Diameter 5 mm | MR Conditional | Available |
| FA-77500-12 | Outer Diameter 5.0 mm; Length 12.0 mm | MR Conditional | Available |
| FA-77500-12 | β | MR Conditional | Available |
| FA-77500-14 | Outer Diameter 5.0 mm; Length 14.0 mm | MR Conditional | Available |
| FA-77500-14 | Length 14 mm; Outer Diameter 5 mm | MR Conditional | Available |
| FA-77500-16 | β | MR Conditional | Available |
| FA-77500-16 | Length 16.0 mm; Outer Diameter 5.0 mm | MR Conditional | Available |
| FA-77500-18 | Length 18 mm; Outer Diameter 5 mm | MR Conditional | Available |
| FA-77500-18 | Length 18.0 mm; Outer Diameter 5.0 mm | MR Conditional | Available |
| FA-77500-18 | β | MR Conditional | Available |
| FA-77500-20 | β | MR Conditional | Available |
| FA-77500-20 | Length 20 mm; Outer Diameter 5 mm | MR Conditional | Available |
| PED-250-10 | Length 10.0 mm | MR Conditional | Available |
| PED-250-10 | Outer Diameter 2.5 mm; Length 10 mm | MR Conditional | Available |
| PED-250-12 | Length 12.0 mm | MR Conditional | Available |
| PED-250-12 | Length 12 mm; Outer Diameter 2.5 mm | MR Conditional | Available |
| PED-250-14 | Length 14 mm; Outer Diameter 2.5 mm | MR Conditional | Available |
| PED-250-16 | Length 16.0 mm | MR Conditional | Available |
| PED-250-16 | Outer Diameter 2.5 mm; Length 16 mm | MR Conditional | Available |
| PED-250-18 | Length 18.0 mm | MR Conditional | Available |
| PED-250-18 | Length 18 mm; Outer Diameter 2.5 mm | MR Conditional | Available |
FDA clearances
- PMA P100018 August 2011
Procedures that use flow diverters
Frequently asked questions
What is Pipeline used for?
A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.
Who makes Pipeline?
Pipeline is made by Micro Therapeutics, Inc.. It is listed under flow diverters in our device library.
What sizes does Pipeline come in?
Sizes listed for Pipeline: Length: 10β35 mm; Outer Diameter: 2.5β5 mm. Confirm availability with the manufacturer's instructions for use.
Is Pipeline MRI safe?
The FDA device database lists Pipeline as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Pipeline FDA cleared?
Pipeline is covered by FDA submission P100018.
How do I contact a Micro Therapeutics, Inc. sales representative?
Micro Therapeutics, Inc. has not listed representatives on LA Vascular yet. Visit the Micro Therapeutics, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.