Dlp® 57414
Dlp® 57414 is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K875353 on 22 Mar 1988 and listed in FDA GUDID since 27 Sep 2024 (UDI-DI 20763000946481), 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 | Number20763000946481 | Date27 Sep 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK875353 | Date22 Mar 1988 | StatusActive |
Official records
- AccessGUDID record 20763000946481
- FDA 510(k) database K875353
Across registries
- FDA 510(k) K875353 decided 22 Mar 1988 Active
- FDA GUDID UDI-DI 20763000946481 listed 27 Sep 2024 Listed
Recalls
-
- Terminated Z-1914-2015
Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion circuit tubing.
Timeline
- Cleared FDA 510(k) K875353
- Recall initiated FDA recalls Z-1914-2015
- Listed FDA GUDID 20763000946481
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dlp®
- Generic name
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
- Model / reference
- 57414
- Primary DI / UDI-DI
- 20763000946481
- 510(k) Number
- FDA product code
- DWF
- GMDN term
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
- Device class
- Class II
- Regulation number
- 870.4210
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Gauge — 14.0 French