Coils
Smart Coil
A collection of sterile devices and supplies used in combination for the implantation of an embolization implant that will purposely create permanent or temporary obstruction, i.e., stop the flow of blood, in arteries/blood vessels. The kit will typically consist of, e.g., an embolization implant, an inserter, a dedicated syringe, and possibly other supplies necessary for the surgical procedure. This is a single-use device.
Smart Coil 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 |
|---|---|---|---|
| 400SMTHXSFT0101 | β | MR Conditional | Available |
| 400SMTHXSFT0102 | β | MR Conditional | Available |
| 400SMTHXSFT0103 | β | MR Conditional | Available |
| 400SMTHXSFT0104 | β | MR Conditional | Available |
| 400SMTHXSFT0105 | β | MR Conditional | Available |
| 400SMTHXSFT011H | β | MR Conditional | Available |
| 400SMTHXSFT0201 | β | MR Conditional | Available |
| 400SMTHXSFT0202 | β | MR Conditional | Available |
| 400SMTHXSFT0203 | β | MR Conditional | Available |
| 400SMTHXSFT0204 | β | MR Conditional | Available |
| 400SMTHXSFT0205 | β | MR Conditional | Available |
| 400SMTHXSFT0206 | β | MR Conditional | Available |
| 400SMTHXSFT0207 | β | MR Conditional | Available |
| 400SMTHXSFT0208 | β | MR Conditional | Available |
| 400SMTHXSFT0209 | β | MR Conditional | Available |
| 400SMTHXSFT0210 | β | MR Conditional | Available |
| 400SMTHXSFT0303 | β | MR Conditional | Available |
| 400SMTHXSFT0304 | β | MR Conditional | Available |
| 400SMTHXSFT0306 | β | MR Conditional | Available |
| 400SMTHXSFT0308 | β | MR Conditional | Available |
| 400SMTHXSFT0310 | β | MR Conditional | Available |
| 400SMTHXSFT0404 | β | MR Conditional | Available |
| 400SMTHXSFT0406 | β | MR Conditional | Available |
| 400SMTHXSFT0408 | β | MR Conditional | Available |
| 400SMTHXSFT0410 | β | MR Conditional | Available |
| 400SMTHXSFT0412 | β | MR Conditional | Available |
| 400SMTHXSFT0415 | β | MR Conditional | Available |
| 400SMTHXSFT0420 | β | MR Conditional | Available |
| 400SMTHXSFT0510 | β | MR Conditional | Available |
| 400SMTHXSFT0515 | β | MR Conditional | Available |
| 400SMTHXSFT0520 | β | MR Conditional | Available |
| 400SMTHXSFT0610 | β | MR Conditional | Available |
| 400SMTHXSFT0615 | β | MR Conditional | Available |
| 400SMTHXSFT0620 | β | MR Conditional | Available |
| 400SMTHXSFT1H01 | β | MR Conditional | Available |
| 400SMTHXSFT1H02 | β | MR Conditional | Available |
| 400SMTHXSFT1H03 | β | MR Conditional | Available |
| 400SMTHXSFT1H04 | β | MR Conditional | Available |
| 400SMTHXSFT1H05 | β | MR Conditional | Available |
| 400SMTHXSFT1H06 | β | MR Conditional | Available |
| 400SMTHXSFT1H1H | β | MR Conditional | Available |
| 400SMTHXSFT2H02 | β | MR Conditional | Available |
| 400SMTHXSFT2H03 | β | MR Conditional | Available |
| 400SMTHXSFT2H04 | β | MR Conditional | Available |
| 400SMTHXSFT2H06 | β | MR Conditional | Available |
| 400SMTHXSFT2H07 | β | MR Conditional | Available |
| 400SMTHXSFT2H08 | β | MR Conditional | Available |
| 400SMTHXSFT2H09 | β | MR Conditional | Available |
| 400SMTHXSFT2H10 | β | MR Conditional | Available |
| 400SMTHXSFT3H04 | β | MR Conditional | Available |
| 400SMTHXSFT3H06 | β | MR Conditional | Available |
| 400SMTHXSFT3H08 | β | MR Conditional | Available |
| 400SMTHXSFT3H10 | β | MR Conditional | Available |
| 400SMTHXSFT3H12 | β | MR Conditional | Available |
| 400SMTHXSFT3H15 | β | MR Conditional | Available |
| 400SMTHXSFT4H06 | β | MR Conditional | Available |
| 400SMTHXSFT4H08 | β | MR Conditional | Available |
| 400SMTHXSFT4H10 | β | MR Conditional | Available |
| 400SMTHXSFT4H12 | β | MR Conditional | Available |
| 400SMTHXSFT4H15 | β | MR Conditional | Available |
| 400SMTHXSFT4H20 | β | MR Conditional | Available |
| 400SMTSFT0202 | β | MR Conditional | Available |
| 400SMTSFT0203 | β | MR Conditional | Available |
| 400SMTSFT0204 | β | MR Conditional | Available |
| 400SMTSFT0304 | β | MR Conditional | Available |
| 400SMTSFT0306 | β | MR Conditional | Available |
| 400SMTSFT0308 | β | MR Conditional | Available |
| 400SMTSFT0310 | β | MR Conditional | Available |
| 400SMTSFT0406 | β | MR Conditional | Available |
| 400SMTSFT0408 | β | MR Conditional | Available |
| 400SMTSFT0410 | β | MR Conditional | Available |
| 400SMTSFT0412 | β | MR Conditional | Available |
| 400SMTSFT0415 | β | MR Conditional | Available |
| 400SMTSFT0420 | β | MR Conditional | Available |
| 400SMTSFT0506 | β | MR Conditional | Available |
| 400SMTSFT0508 | β | MR Conditional | Available |
| 400SMTSFT0510 | β | MR Conditional | Available |
| 400SMTSFT0515 | β | MR Conditional | Available |
| 400SMTSFT0520 | β | MR Conditional | Available |
| 400SMTSFT0608 | β | MR Conditional | Available |
| 400SMTSFT0610 | β | MR Conditional | Available |
| 400SMTSFT0615 | β | MR Conditional | Available |
| 400SMTSFT0620 | β | MR Conditional | Available |
| 400SMTSFT0710 | β | MR Conditional | Available |
| 400SMTSFT0715 | β | MR Conditional | Available |
| 400SMTSFT0720 | β | MR Conditional | Available |
| 400SMTSFT0730 | β | MR Conditional | Available |
| 400SMTSFT0815 | β | MR Conditional | Available |
| 400SMTSFT0820 | β | MR Conditional | Available |
| 400SMTSFT0830 | β | MR Conditional | Available |
| 400SMTSFT0915 | β | MR Conditional | Available |
| 400SMTSFT0920 | β | MR Conditional | Available |
| 400SMTSFT0930 | β | MR Conditional | Available |
| 400SMTSFT2H03 | β | MR Conditional | Available |
| 400SMTSFT2H04 | β | MR Conditional | Available |
| 400SMTSFT2H05 | β | MR Conditional | Available |
| 400SMTSFT2H06 | β | MR Conditional | Available |
| 400SMTSFT3H04 | β | MR Conditional | Available |
| 400SMTSFT3H06 | β | MR Conditional | Available |
| 400SMTSFT3H08 | β | MR Conditional | Available |
| 400SMTSFT3H10 | β | MR Conditional | Available |
| 400SMTSFT4H06 | β | MR Conditional | Available |
| 400SMTSFT4H08 | β | MR Conditional | Available |
| 400SMTSFT4H10 | β | MR Conditional | Available |
| 400SMTSFT4H12 | β | MR Conditional | Available |
| 400SMTSFT4H15 | β | MR Conditional | Available |
| 400SMTSFT4H20 | β | MR Conditional | Available |
| 400SMTSFT1020 | β | MR Conditional | Available |
| 400SMTSFT1030 | β | MR Conditional | Available |
| 400SMTSFT1045 | β | MR Conditional | Available |
| 400SMTSFT1130 | β | MR Conditional | Available |
| 400SMTSFT1145 | β | MR Conditional | Available |
| 400SMTSFT1230 | β | MR Conditional | Available |
| 400SMTSFT1245 | β | MR Conditional | Available |
| 400SMTSFT1330 | β | MR Conditional | Available |
| 400SMTSFT1345 | β | MR Conditional | Available |
| 400SMTSFT1430 | β | MR Conditional | Available |
| 400SMTSFT1445 | β | MR Conditional | Available |
| 400SMTSTD0304 | β | MR Conditional | Available |
| 400SMTSTD0305 | β | MR Conditional | Available |
| 400SMTSTD0306 | β | MR Conditional | Available |
| 400SMTSTD0406 | β | MR Conditional | Available |
| 400SMTSTD0408 | β | MR Conditional | Available |
| 400SMTSTD0410 | β | MR Conditional | Available |
| 400SMTSTD0412 | β | MR Conditional | Available |
| 400SMTSTD0415 | β | MR Conditional | Available |
| 400SMTSTD0420 | β | MR Conditional | Available |
| 400SMTSTD0508 | β | MR Conditional | Available |
| 400SMTSTD0510 | β | MR Conditional | Available |
| 400SMTSTD0515 | β | MR Conditional | Available |
| 400SMTSTD0520 | β | MR Conditional | Available |
| 400SMTSTD0610 | β | MR Conditional | Available |
| 400SMTSTD0615 | β | MR Conditional | Available |
| 400SMTSTD0620 | β | MR Conditional | Available |
| 400SMTSTD0625 | β | MR Conditional | Available |
| 400SMTSTD0715 | β | MR Conditional | Available |
| 400SMTSTD0720 | β | MR Conditional | Available |
| 400SMTSTD0725 | β | MR Conditional | Available |
| 400SMTSTD0730 | β | MR Conditional | Available |
| 400SMTSTD0820 | β | MR Conditional | Available |
| 400SMTSTD0825 | β | MR Conditional | Available |
| 400SMTSTD0830 | β | MR Conditional | Available |
| 400SMTSTD0835 | β | MR Conditional | Available |
| 400SMTSTD0920 | β | MR Conditional | Available |
| 400SMTSTD0925 | β | MR Conditional | Available |
| 400SMTSTD0930 | β | MR Conditional | Available |
| 400SMTSTD0935 | β | MR Conditional | Available |
| 400SMTSTD0945 | β | MR Conditional | Available |
| 400SMTSTD3H05 | β | MR Conditional | Available |
| 400SMTSTD3H06 | β | MR Conditional | Available |
| 400SMTSTD3H08 | β | MR Conditional | Available |
| 400SMTSTD3H10 | β | MR Conditional | Available |
| 400SMTSTD4H06 | β | MR Conditional | Available |
| 400SMTSTD4H08 | β | MR Conditional | Available |
| 400SMTSTD4H10 | β | MR Conditional | Available |
| 400SMTSTD4H12 | β | MR Conditional | Available |
| 400SMTSTD4H15 | β | MR Conditional | Available |
| 400SMTSTD4H20 | β | MR Conditional | Available |
| 400SMTSTD1030 | β | MR Conditional | Available |
| 400SMTSTD1045 | β | MR Conditional | Available |
| 400SMTSTD1135 | β | MR Conditional | Available |
| 400SMTSTD1145 | β | MR Conditional | Available |
| 400SMTSTD1160 | β | MR Conditional | Available |
| 400SMTSTD1235 | β | MR Conditional | Available |
| 400SMTSTD1245 | β | MR Conditional | Available |
| 400SMTSTD1260 | β | MR Conditional | Available |
| 400SMTSTD1345 | β | MR Conditional | Available |
| 400SMTSTD1360 | β | MR Conditional | Available |
| 400SMTSTD1445 | β | MR Conditional | Available |
| 400SMTSTD1460 | β | MR Conditional | Available |
| 400SMTSTD1545 | β | MR Conditional | Available |
| 400SMTSTD1560 | β | MR Conditional | Available |
| 400SMTSTD1645 | β | MR Conditional | Available |
| 400SMTSTD1660 | β | MR Conditional | Available |
| 400SMTSTD1845 | β | MR Conditional | Available |
| 400SMTSTD1860 | β | MR Conditional | Available |
| 400SMTXSFT0101 | β | MR Conditional | Available |
| 400SMTXSFT0102 | β | MR Conditional | Available |
| 400SMTXSFT0103 | β | MR Conditional | Available |
| 400SMTXSFT0104 | β | MR Conditional | Available |
| 400SMTXSFT0105 | β | MR Conditional | Available |
| 400SMTXSFT011H | β | MR Conditional | Available |
| 400SMTXSFT0201 | β | MR Conditional | Available |
| 400SMTXSFT0202 | β | MR Conditional | Available |
| 400SMTXSFT0203 | β | MR Conditional | Available |
| 400SMTXSFT0204 | β | MR Conditional | Available |
| 400SMTXSFT0205 | β | MR Conditional | Available |
| 400SMTXSFT0206 | β | MR Conditional | Available |
| 400SMTXSFT0207 | β | MR Conditional | Available |
| 400SMTXSFT0208 | β | MR Conditional | Available |
| 400SMTXSFT0209 | β | MR Conditional | Available |
| 400SMTXSFT0210 | β | MR Conditional | Available |
| 400SMTXSFT0303 | β | MR Conditional | Available |
| 400SMTXSFT0304 | β | MR Conditional | Available |
| 400SMTXSFT0306 | β | MR Conditional | Available |
| 400SMTXSFT0308 | β | MR Conditional | Available |
| 400SMTXSFT0310 | β | MR Conditional | Available |
| 400SMTXSFT0404 | β | MR Conditional | Available |
| 400SMTXSFT0406 | β | MR Conditional | Available |
| 400SMTXSFT0408 | β | MR Conditional | Available |
| 400SMTXSFT0410 | β | MR Conditional | Available |
| 400SMTXSFT0412 | β | MR Conditional | Available |
| 400SMTXSFT0415 | β | MR Conditional | Available |
| 400SMTXSFT0420 | β | MR Conditional | Available |
| 400SMTXSFT0510 | β | MR Conditional | Available |
| 400SMTXSFT0515 | β | MR Conditional | Available |
| 400SMTXSFT0520 | β | MR Conditional | Available |
| 400SMTXSFT0610 | β | MR Conditional | Available |
| 400SMTXSFT0615 | β | MR Conditional | Available |
| 400SMTXSFT0620 | β | MR Conditional | Available |
| 400SMTXSFT1H01 | β | MR Conditional | Available |
| 400SMTXSFT1H02 | β | MR Conditional | Available |
| 400SMTXSFT1H03 | β | MR Conditional | Available |
| 400SMTXSFT1H04 | β | MR Conditional | Available |
| 400SMTXSFT1H05 | β | MR Conditional | Available |
| 400SMTXSFT1H06 | β | MR Conditional | Available |
| 400SMTXSFT1H1H | β | MR Conditional | Available |
| 400SMTXSFT2H02 | β | MR Conditional | Available |
| 400SMTXSFT2H03 | β | MR Conditional | Available |
| 400SMTXSFT2H04 | β | MR Conditional | Available |
| 400SMTXSFT2H06 | β | MR Conditional | Available |
| 400SMTXSFT2H07 | β | MR Conditional | Available |
| 400SMTXSFT2H08 | β | MR Conditional | Available |
| 400SMTXSFT2H09 | β | MR Conditional | Available |
| 400SMTXSFT2H10 | β | MR Conditional | Available |
| 400SMTXSFT3H04 | β | MR Conditional | Available |
| 400SMTXSFT3H06 | β | MR Conditional | Available |
| 400SMTXSFT3H08 | β | MR Conditional | Available |
| 400SMTXSFT3H10 | β | MR Conditional | Available |
| 400SMTXSFT3H12 | β | MR Conditional | Available |
| 400SMTXSFT3H15 | β | MR Conditional | Available |
| 400SMTXSFT4H06 | β | MR Conditional | Available |
| 400SMTXSFT4H08 | β | MR Conditional | Available |
| 400SMTXSFT4H10 | β | MR Conditional | Available |
| 400SMTXSFT4H12 | β | MR Conditional | Available |
| 400SMTXSFT4H15 | β | MR Conditional | Available |
| 400SMTXSFT4H20 | β | MR Conditional | Available |
| RBYLP0410 | Length 10 cm | MR Conditional | Available |
FDA clearances
- 510(k) K192955 November 2019
- 510(k) K160832 April 2016
- 510(k) K151572 July 2015
- 510(k) K143218 March 2015
Procedures that use coils
Frequently asked questions
What is Smart Coil used for?
A collection of sterile devices and supplies used in combination for the implantation of an embolization implant that will purposely create permanent or temporary obstruction, i.e., stop the flow of blood, in arteries/blood vessels. The kit will typically consist of, e.g., an embolization implant, an inserter, a dedicated syringe, and possibly other supplies necessary for the surgical procedure. This is a single-use device.
Who makes Smart Coil?
Smart Coil is made by Penumbra, Inc.. It is listed under embolization coils in our device library.
What sizes does Smart Coil come in?
Sizes listed for Smart Coil: Length: 10 cm. Confirm availability with the manufacturer's instructions for use.
Is Smart Coil MRI safe?
The FDA device database lists Smart Coil as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Smart Coil FDA cleared?
Smart Coil is covered by FDA submissions K143218, K151572, K160832, K192955.
How do I contact a Penumbra, Inc. sales representative?
Penumbra, Inc. has not listed representatives on LA Vascular yet. Visit the Penumbra, 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.