Identity
- Trade Name
- ClosureFast FDA UDI
- Generic Name
- Peripheral vascular electrocautery catheter, single-use FDA UDI
- Device Name
- Endovenous Radiofrequency Ablation (RFA) Catheter,7 cm Heating Element,7 Fr/Ch (2.3 mm) x 100 cm FDA UDI
- Model / Reference
- CF7-7-100 FDA UDI
- Description
- Endovenous Radiofrequency Ablation (RFA) Catheter,7 cm Heating Element,7 Fr/Ch (2.3 mm) x 100 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521058057 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Centimeter FDA UDICatheter Gauge — 7 French FDA UDI
Category: Peripheral vascular electrocautery catheter, single-use
ClosureFast by Covidien LP — 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
- Venclose™ EVSRF™ Catheter — VENCLOSE INC · Class II
- Venclose™ EVSRF™ Catheter — VENCLOSE INC · Class II
- Venclose™ EVSRF™ Catheter — VENCLOSE INC · Class II
- Venclose Maven Catheter — VENCLOSE INC · Class II
- ClosureFast™ — MEDTRONIC, INC. · Class II
- Curaway — Zhejiang CuraWay Medical Technology Co., Ltd. · Class II
Cleared under the same submission
K111887 also covers:
K223488 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
- Covidien LP
Sources (1)
- FDA UDI 5266da4e-4dff-42a3-ae39-454ca10bbf51 37 fields · synced May 31, 2026