Swift-Lock™ 1192
by St. Jude Medical, Inc. 2 variants
Swift-Lock™ 1192 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K092371 on 23 Dec 2009 and listed in FDA GUDID since 4 Aug 2015 (UDI-DI 05414734400671), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05414734400671 | Date4 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092371 | Date23 Dec 2009 | StatusActive |
Official records
- AccessGUDID record 05414734400671
- FDA 510(k) database K092371
Across registries
- FDA 510(k) K092371 decided 23 Dec 2009 Active
- FDA GUDID UDI-DI 05414734400671 listed 4 Aug 2015 Listed
Recalls
-
- Terminated Z-1425-2010
Directions For Use of product incorrectly stated lead compatibility information.
Timeline
- Cleared FDA 510(k) K092371
- Recall initiated FDA recalls Z-1425-2010
- Listed FDA GUDID 05414734400671
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Swift-Lock™
- Generic name
- Electrical cable/lead holder
- Model / Ref / Catalog
- 1192
- Primary DI / UDI-DI
- 05414734400671
- 510(k) Number
- FDA product code
- GZB
- GMDN term
- Electrical cable/lead holder
- Device class
- Class II
- Regulation number
- 882.5880
- GUDID distribution status
- In Commercial Distribution