DTJ
12 FDA 510(k) clearances · Product code
52 daysmedian time to decision
90 days90th percentile
12clearances measured
FDA profile
- Official device name
- Holder, Heart-Valve, Prosthesis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3935
- Medical specialty
- Cardiovascular
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CARBOMEDICS HANDLE (K962154) | Carbomedics, Inc. | 1996-08-27 |
| CARBOMEDICS VALVE TESTER (K960169) | Carbomedics, Inc. | 1996-04-15 |
| BAXTER HANDLE MODEL 1150 (K944214) | Baxter Edwards | 1995-02-10 |
| CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE (K942736) | Carbomedics, Inc. | 1994-07-06 |
| EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR (K880052) | Baxter Healthcare Corp | 1988-04-01 |
| IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) (K871596) | Shiley, Inc. | 1987-06-15 |
| MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (K864155) | American Edwards Laboratories | 1986-11-20 |
| IONESCU-SHILEY VALVE HOLDER & HANDLE (K813276) | Shiley, Inc. | 1981-12-10 |
| DISPOSABLE HOLDER FOR HANCOCK MITRAL (K811235) | Vascor, Inc. | 1981-05-13 |
| DISPOSABLE HOLDER FOR HANCOCK AORTIC (K811236) | Vascor, Inc. | 1981-05-13 |
| INTEGRAL DISPOSABLE HOLDER CARPENTIER (K792034) | Edwards Laboratories | 1979-12-07 |
| DISPOSABLE HOLDER FOR BIOPROSTHESIS (K790022) | Edwards Laboratories | 1979-01-15 |
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Every clearance here is in the API, with alerts when new ones post.