Product code DTJ
- Device name
- Holder, Heart-Valve, Prosthesis
- Medical specialty
- Cardiovascular
- Device class
- 1
- Regulation number
- 870.3935
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962154 | CARBOMEDICS HANDLE | Carbomedics, Inc. | 1996-08-27 |
| K960169 | CARBOMEDICS VALVE TESTER | Carbomedics, Inc. | 1996-04-15 |
| K944214 | BAXTER HANDLE MODEL 1150 | Baxter Edwards | 1995-02-10 |
| K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | Carbomedics, Inc. | 1994-07-06 |
| K880052 | EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR | Baxter Healthcare Corp | 1988-04-01 |
| K871596 | IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) | Shiley, Inc. | 1987-06-15 |
| K864155 | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS | American Edwards Laboratories | 1986-11-20 |
| K813276 | IONESCU-SHILEY VALVE HOLDER & HANDLE | Shiley, Inc. | 1981-12-10 |
| K811235 | DISPOSABLE HOLDER FOR HANCOCK MITRAL | Vascor, Inc. | 1981-05-13 |
| K811236 | DISPOSABLE HOLDER FOR HANCOCK AORTIC | Vascor, Inc. | 1981-05-13 |
| K792034 | INTEGRAL DISPOSABLE HOLDER CARPENTIER | Edwards Laboratories | 1979-12-07 |
| K790022 | DISPOSABLE HOLDER FOR BIOPROSTHESIS | Edwards Laboratories | 1979-01-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00613994163516 | Annuloplasty Handle | MEDTRONIC, INC. | 2025-12-22 |
| 00613994862488 | Annuloplasty Handle | MEDTRONIC, INC. | 2025-12-22 |
| 00643169525610 | Annuloplasty Handle | MEDTRONIC, INC. | 2025-12-22 |
| 00643169525634 | Annuloplasty Handle | MEDTRONIC, INC. | 2025-12-22 |
| 00643169525641 | Annuloplasty Handle | MEDTRONIC, INC. | 2025-12-22 |
| 00721902450358 | Valve Handle | MEDTRONIC, INC. | 2025-12-22 |
| 00885074394848 | Valve Handle | MEDTRONIC, INC. | 2025-12-22 |
| 00763000658960 | Profile 3D™ | MEDTRONIC, INC. | 2025-08-21 |
| 00763000658977 | Profile 3D™ | MEDTRONIC, INC. | 2025-07-19 |
| 00763000658953 | Profile 3D™ | MEDTRONIC, INC. | 2025-07-19 |
| 00643169739246 | Avalus™ | MEDTRONIC, INC. | 2025-05-31 |
| 00613994163523 | Duran AnCore | MEDTRONIC, INC. | 2025-05-30 |
| 00643169525627 | Annuloplasty Handle | MEDTRONIC, INC. | 2025-05-30 |
| 00643169554139 | Valve Handle | MEDTRONIC, INC. | 2025-05-30 |
| 00643169554146 | Valve Handle | MEDTRONIC, INC. | 2025-05-30 |
| 00643169624955 | Open Pivot™ | MEDTRONIC, INC. | 2025-05-30 |
| 00643169624986 | Open Pivot™ | MEDTRONIC, INC. | 2025-05-30 |
| 00763000612351 | Annuloplasty Handle | MEDTRONIC, INC. | 2025-03-20 |
| 00763000612368 | Annuloplasty Handle | MEDTRONIC, INC. | 2025-03-20 |
| 00763000613648 | NA | MEDTRONIC, INC. | 2025-03-03 |
| 00763000613655 | NA | MEDTRONIC, INC. | 2025-03-03 |
| 00763000582906 | Valve Handle 7420 | MEDTRONIC, INC. | 2025-02-23 |
| 00690103210132 | MITRIS Handle 1140M | Edwards Lifesciences LLC | 2024-10-18 |
| 00690103166989 | HEART VALVE ACCESSOR | Edwards Lifesciences LLC | 2024-10-18 |
| 00690103177701 | A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46 | Edwards Lifesciences LLC | 2024-10-18 |
| 00690103186437 | FLEXIBLE HANDLE | Edwards Lifesciences LLC | 2024-10-18 |
| 00690103019339 | HEART VALVE ACCESSOR | Edwards Lifesciences LLC | 2024-10-18 |
| 00690103019063 | HEART VALVE HANDLE ACCESSORY | Edwards Lifesciences LLC | 2024-10-18 |
| 05415067042293 | Masters Series™ | ST. JUDE MEDICAL, INC. | 2023-02-17 |
| 05415067042279 | Regent™ | ST. JUDE MEDICAL, INC. | 2023-02-17 |