DTJ · Holder, Heart-Valve, Prosthesis
Cardiovascular · 21 CFR 870.3935 · Class 1
Overview
| Product Code | DTJ |
|---|---|
| Device Name | Holder, Heart-Valve, Prosthesis |
| Regulation | 21 CFR 870.3935 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.
Classification Rationale
Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962154 | CARBOMEDICS HANDLE | Carbomedics, Inc. | Aug 27, 1996 | SESE |
| K960169 | CARBOMEDICS VALVE TESTER | Carbomedics, Inc. | Apr 15, 1996 | SESE |
| K944214 | BAXTER HANDLE MODEL 1150 | Baxter Edwards | Feb 10, 1995 | SESE |
| K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | Carbomedics, Inc. | Jul 6, 1994 | SESE |
| K880052 | EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR | Baxter Healthcare Corp | Apr 1, 1988 | SESE |
| K871596 | IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) | Shiley, Inc. | Jun 15, 1987 | SESE |
| K864155 | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS | American Edwards Laboratories | Nov 20, 1986 | SESE |
| K813276 | IONESCU-SHILEY VALVE HOLDER & HANDLE | Shiley, Inc. | Dec 10, 1981 | SESE |
| K811236 | DISPOSABLE HOLDER FOR HANCOCK AORTIC | Vascor, Inc. | May 13, 1981 | SESE |
| K811235 | DISPOSABLE HOLDER FOR HANCOCK MITRAL | Vascor, Inc. | May 13, 1981 | SESE |
| K792034 | INTEGRAL DISPOSABLE HOLDER CARPENTIER | Edwards Laboratories | Dec 7, 1979 | SESE |
| K790022 | DISPOSABLE HOLDER FOR BIOPROSTHESIS | Edwards Laboratories | Jan 15, 1979 | SESE |
Top Applicants
- Carbomedics, Inc. — 3 clearances
- Edwards Laboratories — 2 clearances
- Shiley, Inc. — 2 clearances
- Vascor, Inc. — 2 clearances
- American Edwards Laboratories — 1 clearance
