510(k) K871596
- Device
- IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)
- Applicant
- SHILEY, INC.
- 510(k) number
- K871596
- Product code
- DTJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-06-15
- Date received
- 1987-04-24
- 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
- RADINE POBUDA
- Address
- 17600 Gillette Ave. P.O. Box 19503 Irvine CA US 92714 92714
FDA Registration Numbers#
- 2015691
- 1721676
- 2025587
- 3005687633
- 3008500478
- 2133928
- 1063481
- 2134285
- 3008592544
- 3010701807
- 2135147
- 3007113487
- 1649833
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 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases