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DTJ — Holder, Heart-Valve, Prosthesis Class I

FDA Device Classification

Classification Details

Product Code
DTJ
Device Class
Class I
Regulation Number
870.3935
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K962154carbomedicsCARBOMEDICS HANDLEAugust 27, 1996
K960169carbomedicsCARBOMEDICS VALVE TESTERApril 15, 1996
K944214baxter edwardsBAXTER HANDLE MODEL 1150February 10, 1995
K942736carbomedicsCARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLEJuly 6, 1994
K880052baxter healthcareEDWARDS-DUROMEDICS MITRAL VALVE ROTATORApril 1, 1988
K871596shileyIONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)June 15, 1987
K864155american edwards laboratoriesMODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESISNovember 20, 1986
K813276shileyIONESCU-SHILEY VALVE HOLDER & HANDLEDecember 10, 1981
K811236vascorDISPOSABLE HOLDER FOR HANCOCK AORTICMay 13, 1981
K811235vascorDISPOSABLE HOLDER FOR HANCOCK MITRALMay 13, 1981
K792034edwards laboratoriesINTEGRAL DISPOSABLE HOLDER CARPENTIERDecember 7, 1979
K790022edwards laboratoriesDISPOSABLE HOLDER FOR BIOPROSTHESISJanuary 15, 1979