FDA 510(k) Applications for Medical Device Product Code "DTJ"
(Holder, Heart-Valve, Prosthesis)

FDA 510(k) Number Applicant Device Name Decision Date
K864155 AMERICAN EDWARDS LABORATORIES MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS 11/20/1986
K944214 BAXTER EDWARDS BAXTER HANDLE MODEL 1150 02/10/1995
K880052 BAXTER HEALTHCARE CORP. EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR 04/01/1988
K962154 CARBOMEDICS, INC. CARBOMEDICS HANDLE 08/27/1996
K960169 CARBOMEDICS, INC. CARBOMEDICS VALVE TESTER 04/15/1996
K942736 CARBOMEDICS, INC. CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE 07/06/1994
K790022 EDWARDS LABORATORIES DISPOSABLE HOLDER FOR BIOPROSTHESIS 01/15/1979
K792034 EDWARDS LABORATORIES INTEGRAL DISPOSABLE HOLDER CARPENTIER 12/07/1979
K871596 SHILEY, INC. IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) 06/15/1987
K813276 SHILEY, INC. IONESCU-SHILEY VALVE HOLDER & HANDLE 12/10/1981
K811236 VASCOR, INC. DISPOSABLE HOLDER FOR HANCOCK AORTIC 05/13/1981
K811235 VASCOR, INC. DISPOSABLE HOLDER FOR HANCOCK MITRAL 05/13/1981


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact