Sjm™ 4033
Sjm™ 4033 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K950140 on 6 Apr 1995 and listed in FDA GUDID since 10 Apr 2017 (UDI-DI 05414734506458), 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 | Number05414734506458 | Date10 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK950140 | Date6 Apr 1995 | StatusActive |
Official records
- AccessGUDID record 05414734506458
- FDA 510(k) database K950140
Across registries
- FDA 510(k) K950140 decided 6 Apr 1995 Active
- FDA GUDID UDI-DI 05414734506458 listed 10 Apr 2017 Listed
Timeline
- Cleared FDA 510(k) K950140
- Listed FDA GUDID 05414734506458
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sjm™
- Generic name
- Pacing/defibrillation lead cap
- Model / Ref / Catalog
- 4033
- Primary DI / UDI-DI
- 05414734506458
- 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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