Identity
- Trade Name
- ClosureRFS™ EUDAMEDFDA UDI
- Generic Name
- Peripheral vascular radio-frequency ablation catheter FDA UDI
- Device Name
- ClosureRFS Stylet EUDAMEDSTYLET RFS2-6-12 CLOSUREFAST FDA UDI
- Model / Reference
- RFS2-6-12 EUDAMEDFDA UDI
- Description
- STYLET RFS2-6-12 CLOSUREFAST FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000723293 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763000B00004067E EUDAMED
- 510(k) Number
- K052003 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- C0190190401 CATHETERS FOR RADIOFREQUENCY ENDOVENOUS ABLATION EUDAMED
- GMDN Term
- Peripheral vascular radio-frequency ablation catheter FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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 — 12.0 Centimeter FDA UDI
Category: Peripheral vascular radio-frequency ablation catheter
ClosureRFS™ by Medtronic, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K052003 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (2)
- FDA UDI 1ec809b6-f276-430b-878b-6457b45d4696 37 fields · synced Jul 9, 2026
- EUDAMED 1c24c269-eff7-41fc-9371-51821f2b4d2e 61 fields · synced Jul 9, 2026