Celsius D7BTBL252RT
Celsius D7BTBL252RT is a Class II device made by Biosense Webster Inc, approved under FDA PMA P950005 on 30 Sep 1997 and listed in FDA GUDID since 10 Sep 2014 (UDI-DI 10846835005141), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10846835005141 | Date10 Sep 2014 | StatusListed |
| United States | FDA PMAAPPR | NumberP950005 | Date30 Sep 1997 | StatusActive |
Official records
- AccessGUDID record 10846835005141
- FDA PMA database P950005
Across registries
- FDA PMA P950005 decided 30 Sep 1997 Active
- FDA GUDID UDI-DI 10846835005141 listed 10 Sep 2014 Listed
Timeline
- Approved FDA PMA P950005
- Listed FDA GUDID 10846835005141
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Celsius
- Generic name
- Cardiac radio-frequency ablation system catheter
- Model / Ref / Catalog
- D7BTBL252RT
- Primary DI / UDI-DI
- 10846835005141
- PMA number
- FDA product code
- DRF
- GMDN term
- Cardiac radio-frequency ablation system catheter
- Device class
- Class II
- Regulation number
- 870.1220
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Cardiac radio-frequency ablation system catheter.