510(k) K864155
- Device
- MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
- Applicant
- AMERICAN EDWARDS LABORATORIES
- 510(k) number
- K864155
- Product code
- DTJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-20
- Date received
- 1986-10-23
- Regulation
- 870.3935
- Classification name
- Holder, Heart-valve, Prosthesis
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHERRIN BAKY
- Address
- P.O. Box 11150 17221 Red Hill Ave.(Irvine) Santa Ana CA US 92711 92711
FDA Registration Numbers#
- 1721676
- 3007113487
- 3005687633
- 1063481
- 2025587
- 2015691
- 3010701807
- 3008500478
- 1649833
- 2133928
- 2134285
- 3008592544
- 2135147
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DTJ #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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