FDA Product Code
FDA Product Code DTJ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3935
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K962154 | CARBOMEDICS HANDLE | Carbomedics, Inc. | 1996-08-27 | Traditional | PDF ↗ |
| K960169 | CARBOMEDICS VALVE TESTER | Carbomedics, Inc. | 1996-04-15 | Traditional | PDF ↗ |
| K944214 | BAXTER HANDLE MODEL 1150 | Baxter Edwards | 1995-02-10 | Traditional | PDF ↗ |
| K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | Carbomedics, Inc. | 1994-07-06 | Traditional | PDF ↗ |
| K880052 | EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR | Baxter Healthcare Corp | 1988-04-01 | Traditional | PDF ↗ |
| K871596 | IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) | Shiley, Inc. | 1987-06-15 | Traditional | PDF ↗ |
| K864155 | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS | American Edwards Laboratories | 1986-11-20 | Traditional | PDF ↗ |
| K813276 | IONESCU-SHILEY VALVE HOLDER & HANDLE | Shiley, Inc. | 1981-12-10 | Traditional | PDF ↗ |
| K811236 | DISPOSABLE HOLDER FOR HANCOCK AORTIC | Vascor, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K811235 | DISPOSABLE HOLDER FOR HANCOCK MITRAL | Vascor, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K792034 | INTEGRAL DISPOSABLE HOLDER CARPENTIER | Edwards Laboratories | 1979-12-07 | Traditional | PDF ↗ |
| K790022 | DISPOSABLE HOLDER FOR BIOPROSTHESIS | Edwards Laboratories | 1979-01-15 | Traditional | PDF ↗ |
Product code DTJ · Class I · Cardiovascular. Data: openFDA.