Peripheral stents
Protégé EverFlex
by EV3, Inc
A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.
Protégé EverFlex 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 |
|---|---|---|---|
| PRB35-05-020-080 | Length 20.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| PRB35-05-020-120 | Length 20.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| PRB35-05-030-080 | Length 30.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| PRB35-05-030-120 | Catheter Gauge 6.0 Fr; Length 30.0 mm | MR Conditional | Available |
| PRB35-05-040-080 | Length 40.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| PRB35-05-040-120 | Length 40.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| PRB35-05-060-080 | Length 60.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| PRB35-05-060-120 | Catheter Gauge 6.0 Fr; Length 60.0 mm | MR Conditional | Available |
| PRB35-05-080-080 | Catheter Gauge 6.0 Fr; Length 80.0 mm | MR Conditional | Available |
| PRB35-05-080-120 | Length 80.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| PRB35-05-100-080 | Catheter Gauge 6.0 Fr; Length 100.0 mm | MR Conditional | Available |
| PRB35-05-100-120 | Length 100.0 mm; Catheter Gauge 6.0 Fr | MR Conditional | Available |
| PRB35-05-120-080 | Catheter Gauge 6.0 Fr; Length 120.0 mm | MR Conditional | Available |
| PRB35-05-120-120 | Catheter Gauge 6.0 Fr; Length 120.0 mm | MR Conditional | Available |
FDA clearances
- 510(k) K072301 March 2008
Procedures that use peripheral stents
Frequently asked questions
What is Protégé EverFlex used for?
A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.
Who makes Protégé EverFlex?
Protégé EverFlex is made by EV3, Inc. It is listed under peripheral artery stents and covered stents, biliary drainage catheters in our device library.
What sizes does Protégé EverFlex come in?
Sizes listed for Protégé EverFlex: Catheter Gauge: 6 Fr; Length: 20–120 mm. Confirm availability with the manufacturer's instructions for use.
Is Protégé EverFlex MRI safe?
The FDA device database lists Protégé EverFlex as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Protégé EverFlex FDA cleared?
Protégé EverFlex is covered by FDA submission K072301.
How do I contact a EV3, Inc sales representative?
EV3, Inc has not listed representatives on LA Vascular yet. Visit the EV3, 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.