Identity
- Trade Name
- Venclose™ EVSRF™ Catheter FDA UDI
- Generic Name
- Peripheral vascular electrocautery catheter, single-use FDA UDI
- Device Name
- Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm, 5 pack FDA UDI
- Model / Reference
- VC-10A2.5-6F-60 [5X] FDA UDI
- Description
- Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm, 5 pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858254006169 FDA UDI
- 510(k) Number
- K160754 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Peripheral vascular electrocautery catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 60 Centimeter FDA UDI
Category: Peripheral vascular electrocautery catheter, single-use
Venclose™ EVSRF™ Catheter by Venclose Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular electrocautery catheter, single-use.
- Curaway — Zhejiang CuraWay Medical Technology Co., Ltd. · Class II
- ClosureRFS™ — MEDTRONIC, INC. · Class II
- ClosureFast — Covidien LP · Class II
- ClosureFast™ — MEDTRONIC, INC. · Class II
- ClosureFast — Covidien LP · Class II
- Curaway — Zhejiang CuraWay Medical Technology Co., Ltd. · Class II
- ClosureRFS — Covidien LP · Class II
- ClosureFast™ — MEDTRONIC, INC. · Class II
Cleared under the same submission
K160754 also covers:
- Venclose System Foot Pedal — VENCLOSE INC
- Venclose System Power Cord — VENCLOSE INC
- Venclose System Power Cord — VENCLOSE INC
- Venclose System Power Cord — VENCLOSE INC
- Venclose System Power Cord — VENCLOSE INC
- Venclose System Power Cord — VENCLOSE INC
- Venclose System Power Cord — VENCLOSE INC
- Venclose™ EVSRF™ Catheter — VENCLOSE INC
- Venclose™ EVSRF™ Catheter — VENCLOSE 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 II | Pending data |
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Manufacturer
- Manufacturer
- Venclose Inc
Sources (1)
- FDA UDI 5064430b-3ed2-4602-8a99-cc40acbfd0eb 35 fields · synced May 30, 2026