Panels › Cardiovascular › Product code DTJ · Class 1
Holder, Heart-Valve, Prosthesis
Regulation 870.3935
0510(k)s in 12 months (12 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in DTJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Carbomedics, Inc. | 3 | 1 |
| Edwards Laboratories | 2 | 0 |
| Shiley, Inc. | 2 | 0 |
| Vascor, Inc. | 2 | 0 |
| American Edwards Laboratories | 1 | 0 |
| Baxter Edwards | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 1996 | K962154 | CARBOMEDICS HANDLE Carbomedics, Inc. | DTJ |
| Apr 15, 1996 | K960169 | CARBOMEDICS VALVE TESTER Carbomedics, Inc. | DTJ |
| Feb 10, 1995 | K944214 | BAXTER HANDLE MODEL 1150 Baxter Edwards | DTJ |
| Jul 6, 1994 | K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE Carbomedics, Inc. | DTJ |
| Apr 1, 1988 | K880052 | EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR Baxter Healthcare Corp | DTJ |
| Jun 15, 1987 | K871596 | IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) Shiley, Inc. | DTJ |
| Nov 20, 1986 | K864155 | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS American Edwards Laboratories | DTJ |
| Dec 10, 1981 | K813276 | IONESCU-SHILEY VALVE HOLDER & HANDLE Shiley, Inc. | DTJ |
| May 13, 1981 | K811236 | DISPOSABLE HOLDER FOR HANCOCK AORTIC Vascor, Inc. | DTJ |
| May 13, 1981 | K811235 | DISPOSABLE HOLDER FOR HANCOCK MITRAL Vascor, Inc. | DTJ |
| Dec 7, 1979 | K792034 | INTEGRAL DISPOSABLE HOLDER CARPENTIER Edwards Laboratories | DTJ |
| Jan 15, 1979 | K790022 | DISPOSABLE HOLDER FOR BIOPROSTHESIS Edwards Laboratories | DTJ |
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