MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
FDA 510(k) clearance K864155 · decided 1986-11-20
Clearance details
- K-number
- K864155
- Device name
- MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
- Applicant
- American Edwards Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1986-10-23
- Decision date
- 1986-11-20
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DTJ
- Device class
- 1
- Regulation number
- 870.3935
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GARREN GASTRIC BUBBLE (P840025/S011) | American Edwards Laboratories | 1987-03-17 |
| GARREN GASTRIC BUBBLE (P840025/S008) | American Edwards Laboratories | 1986-10-16 |
| GARREN GASTRIC BUBBLE (P840025/S006) | American Edwards Laboratories | 1986-07-25 |
| GARREN{TM}-EDWARDS GASTRIC BUBBLE (P840025/S005) | American Edwards Laboratories | 1986-05-12 |
| GARREN GASTRIC BUBBLE (P840025/S003) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S002) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S004) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S001) | American Edwards Laboratories | 1985-12-18 |