Open Pivot™ 505DA26
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00613994960238 | Date23 Sep 2014 | StatusListed |
Recalls
-
- Terminated Z-1533-2020
Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.
-
- Terminated Z-0634-04
Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Open Pivot™
- Generic Name
- Aortic bi-leaflet mechanical heart valve prosthesis
- Model / Reference
- 505DA26
- Primary DI / UDI-DI
- 00613994960238
- PMA Number
- FDA Product Code
- LWQ
- GMDN Term
- Aortic bi-leaflet mechanical heart valve prosthesis
- Device Class
- Class III
- GUDID distribution status
- Not in Commercial Distribution
- MRI Safety
- MR Conditional
Other devices from Medtronic, Inc.
Properties
Other properties (9)
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No