Identity
- Trade Name
- EverFlex FDA UDI
- Generic Name
- Peripheral artery stent, bare-metal FDA UDI
- Device Name
- STENT PRB35-06-080-080 PROTEGE EF V10 FDA UDI
- Model / Reference
- PRB35-06-080-080 FDA UDI
- Description
- STENT PRB35-06-080-080 PROTEGE EF V10 FDA UDI
Identifiers
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 80.0 Millimeter FDA UDICatheter Gauge — 6.0 French FDA UDI
Category: Peripheral artery stent, bare-metal
EverFlex by Ev3, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral artery stent, bare-metal.
- Innova™ Vascular — Boston Scientific · Class III
- Pulsar-18 — Biotronik, Inc. · Class III
- LifeStent® Solo Vascular Stent — Bard Peripheral Vascular · Class III
- Astron — Biotronik, Inc. · Class III
- Absolute Pro — Abbott Vascular · Class III
- COMPLETE® SE VASCULAR — MEDTRONIC, INC. · Class III
- Zilver 518 — Cook Ireland, Ltd. · Class III
- Supera™ — Abbott Vascular · Class III
Cleared under the same submission
K060057 also covers:
P110023 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ev3, Inc
Sources (1)
- FDA UDI ce450dd1-68d4-4a5b-9abf-5c6c30dbd856 36 fields · synced May 30, 2026