Identity
- Trade Name
- THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER EUDAMEDThermoCool SF NAV FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system catheter FDA UDI
- Model / Reference
- D131502 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- D131502 FDA UDI
- Primary DI / UDI-DI
- D-USMF000014219000035QP EUDAMED10846835009248 FDA UDI
- Basic UDI-DI
- B-USMF000014219000035QP EUDAMED
- PMA Number
- P030031 FDA UDI
- FDA Product Code
- LPB FDA UDI
- EMDN Code
- C020301 ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS EUDAMED
- GMDN Term
- Cardiac radio-frequency ablation system catheter FDA UDI
Classification
- Device Class
- Class III EUDAMEDFDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Cardiac radio-frequency ablation system catheter
ThermoCool SF NAV by Biosense Webster Inc — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac radio-frequency ablation system catheter.
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Cleared under the same submission
P030031 also covers:
- Celsius RMT ThermoCool — Biosense Webster Inc
- Celsius ThermoCool — Biosense Webster Inc
- Celsius ThermoCool — Biosense Webster Inc
- Celsius ThermoCool — Biosense Webster Inc
- Celsius ThermoCool — Biosense Webster Inc
- EZ Steer ThermoCool — Biosense Webster Inc
- EZ Steer ThermoCool — Biosense Webster Inc
- EZ Steer ThermoCool — Biosense Webster Inc
- EZ Steer ThermoCool — Biosense Webster Inc
- EZ Steer ThermoCool — Biosense Webster Inc
- EZ Steer ThermoCool NAV — Biosense Webster Inc
- EZ Steer ThermoCool NAV — Biosense Webster Inc
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| 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
- Biosense Webster Inc
Sources (2)
- FDA UDI 98920b13-bb3d-4de3-920f-754ae3c9032e 36 fields · synced Jul 12, 2026
- EUDAMED 7ec45ba6-5d3b-4e78-a0ff-0149bf8cfc16 61 fields · synced Jul 12, 2026