Bk-Is 109185
Bk-Is 109185 is a Class II device made by BIOTRONIK SE & Co. KG, cleared under FDA 510(k) K970204 on 29 Apr 1997 and listed in FDA GUDID since 22 Aug 2014 (UDI-DI 04035479144753), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04035479144753 | Date22 Aug 2014 | StatusListed |
| United States | FDA 510(k)SESE | NumberK970204 | Date29 Apr 1997 | StatusActive |
Official records
- AccessGUDID record 04035479144753
- FDA 510(k) database K970204
Across registries
- FDA 510(k) K970204 decided 29 Apr 1997 Active
- FDA GUDID UDI-DI 04035479144753 listed 22 Aug 2014 Listed
Timeline
- Cleared FDA 510(k) K970204
- Listed FDA GUDID 04035479144753
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bk-Is
- Generic name
- Pacing/defibrillation lead cap
- Model / Ref / Catalog
- 109185
- Primary DI / UDI-DI
- 04035479144753
- 510(k) Number
- FDA product code
- DTD
- GMDN term
- Pacing/defibrillation lead cap
- Device class
- Class II
- Regulation number
- 870.3620
- GUDID distribution status
- In Commercial Distribution
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