Identity
- Trade Name
- Protege RX FDA UDI
- Generic Name
- Bare-metal carotid artery stent FDA UDI
- Device Name
- Carotid Stent System FDA UDI
- Model / Reference
- SECX-6-60-135 FDA UDI
- Description
- Carotid Stent System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821684038642 FDA UDI
- PMA Number
- P060001 FDA UDI
- FDA Product Code
- NIM FDA UDI
- GMDN Term
- Bare-metal carotid artery stent FDA UDI
Classification
- Device Class
- Class III 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 60 Millimeter FDA UDICatheter Gauge — 6 French FDA UDI
Category: Bare-metal carotid artery stent
Protege RX by Covidien LP — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal carotid artery stent.
- Cordis PRECISE PRO Rx Nitinol Stent System — Cordis US Corp. · Class III
- ENROUTE Transcarotid Stent — SILK ROAD MEDICAL, INC. · Class III
- Carotid WALLSTENT® — Boston Scientific · Class III
- XACT™ — Abbott Vascular · Class III
- ENROUTE Transcarotid Stent — SILK ROAD MEDICAL, INC. · Class III
- ENROUTE Transcarotid Stent — SILK ROAD MEDICAL, INC. · Class III
- XACT™ — Abbott Vascular · Class III
- Roadsaver Carotid Atery Stent — MICROVENTION INC. · Class III
Cleared under the same submission
P060001 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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 5f133559-5668-4d93-8961-57fc2686f3a8 37 fields · synced May 30, 2026