Identity
- Trade Name
- Duo Extend Venous Stent System FDA UDI
- Generic Name
- Bare-metal peripheral venous stent FDA UDI
- Device Name
- Duo Extend Venous Stent System, 12mm x 120mm Stent, 9F x 120cm Delivery System FDA UDI
- Model / Reference
- N1201212009120 FDA UDI
- Description
- Duo Extend Venous Stent System, 12mm x 120mm Stent, 9F x 120cm Delivery System FDA UDI
Identifiers
- Catalog Number
- N1201212009120 FDA UDI
- Primary DI / UDI-DI
- 00810010693280 FDA UDI
- PMA Number
- P230021 FDA UDI
- FDA Product Code
- QAN FDA UDI
- GMDN Term
- Bare-metal peripheral venous 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Bare-metal peripheral venous stent
Duo Extend Venous Stent System by Vesper Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal peripheral venous stent.
- Venovo® — Angiomed GmbH & Co. Medizintechnik KG · Class III
- VICI RDS™ Venous Stent System — Veniti Inc · Class III
- Venovo® — Angiomed GmbH & Co. Medizintechnik KG · Class III
- Abre™ — MEDTRONIC, INC. · Class III
- VICI RDS™ Venous Stent System — Veniti Inc · Class III
- Venovo® — Angiomed GmbH & Co. Medizintechnik KG · Class III
- Venovo® — Angiomed GmbH & Co. Medizintechnik KG · Class III
- VICI RDS™ Venous Stent System — Veniti Inc · Class III
Cleared under the same submission
P230021 also covers:
- Duo Extend Venous Stent System — Vesper Medical, Inc.
- Duo Extend Venous Stent System — Vesper Medical, Inc.
- Duo Extend Venous Stent System — Vesper Medical, Inc.
- Duo Extend Venous Stent System — Vesper Medical, Inc.
- Duo Hybrid Venous Stent System — Vesper Medical, Inc.
- Duo Hybrid Venous Stent System — Vesper Medical, Inc.
- Duo Hybrid Venous Stent System — Vesper Medical, Inc.
- Duo Hybrid Venous Stent System — Vesper Medical, Inc.
- Duo Hybrid Venous Stent System — Vesper Medical, Inc.
- Duo Hybrid Venous Stent System — Vesper Medical, Inc.
- Duo Hybrid Venous Stent System — Vesper Medical, Inc.
- Duo Hybrid Venous Stent System — Vesper Medical, Inc.
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 |
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Manufacturer
- Manufacturer
- Vesper Medical, Inc.
Sources (1)
- FDA UDI a3953867-8e14-425e-ac6c-1caba323eed2 35 fields · synced May 30, 2026