Holder, Heart-Valve, Prosthesis
The Heart-Valve Prosthesis Holder is a cardiovascular surgical instrument used to hold, position, and deploy a prosthetic heart valve during surgical implantation, providing the surgeon with controlled placement of the valve within the native annulus. It is classified as an FDA Class 1 device, representing the lowest level of regulatory concern, and is subject to general controls only. The product code is DTJ and it is regulated under 21 CFR 870.3935 within the Cardiovascular medical specialty.
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Basic Information
- Product Code
- DTJ
- Device Class
- FDA class 1
- Regulation Number
- 870.3935
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K962154 | CARBOMEDICS HANDLE | Aug 27, 1996 | Substantially Equivalent | Carbomedics, Inc. |
| K960169 | CARBOMEDICS VALVE TESTER | Apr 15, 1996 | Substantially Equivalent | Carbomedics, Inc. |
| K944214 | BAXTER HANDLE MODEL 1150 | Feb 10, 1995 | Substantially Equivalent | Baxter Edwards |
| K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | Jul 06, 1994 | Substantially Equivalent | Carbomedics, Inc. |
| K880052 | EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR | Apr 01, 1988 | Substantially Equivalent | Baxter Healthcare Corp |
| K871596 | IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) | Jun 15, 1987 | Substantially Equivalent | Shiley, Inc. |
| K864155 | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS | Nov 20, 1986 | Substantially Equivalent | American Edwards Laboratories |
| K813276 | IONESCU-SHILEY VALVE HOLDER & HANDLE | Dec 10, 1981 | Substantially Equivalent | Shiley, Inc. |
| K811236 | DISPOSABLE HOLDER FOR HANCOCK AORTIC | May 13, 1981 | Substantially Equivalent | Vascor, Inc. |
| K811235 | DISPOSABLE HOLDER FOR HANCOCK MITRAL | May 13, 1981 | Substantially Equivalent | Vascor, Inc. |
| K792034 | INTEGRAL DISPOSABLE HOLDER CARPENTIER | Dec 07, 1979 | Substantially Equivalent | Edwards Laboratories |
| K790022 | DISPOSABLE HOLDER FOR BIOPROSTHESIS | Jan 15, 1979 | Substantially Equivalent | Edwards Laboratories |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.