Holder, Heart-Valve, Prosthesis
FDA product code DTJ · Class I (low risk) · 21 CFR 870.3935 · Cardiovascular
12510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962154 | Carbomedics HandleDTJ · Traditional | Carbomedics, Inc. | 08/27/1996SE |
| K960169 | Carbomedics Valve TesterDTJ · Traditional | Carbomedics, Inc. | 04/15/1996SE |
| K944214 | Baxter Handle Model 1150DTJ · Traditional | Baxter Edwards | 02/10/1995SE |
| K942736 | Carbomedics(R) Prosthetic Heart Valve Holder HandleDTJ · Traditional | Carbomedics, Inc. | 07/06/1994SE |
| K880052 | Edwards-Duromedics Mitral Valve RotatorDTJ · Traditional | Baxter Healthcare Corp | 04/01/1988SE |
| K871596 | Ionescu-Shiley Pericardial Xenograft (Isu)DTJ · Traditional | Shiley, Inc. | 06/15/1987SE |
| K864155 | Modification of Carpentier-Edwards BioprosthesisDTJ · Traditional | American Edwards Laboratories | 11/20/1986SE |
| K813276 | Ionescu-Shiley Valve Holder & HandleDTJ · Traditional | Shiley, Inc. | 12/10/1981SE |
| K811236 | Disposable Holder for Hancock AorticDTJ · Traditional | Vascor, Inc. | 05/13/1981SE |
| K811235 | Disposable Holder for Hancock MitralDTJ · Traditional | Vascor, Inc. | 05/13/1981SE |
| K792034 | Integral Disposable Holder CarpentierDTJ · Traditional | Edwards Laboratories | 12/07/1979SE |
| K790022 | Disposable Holder for BioprosthesisDTJ · Traditional | Edwards Laboratories | 01/15/1979SE |