BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CARBOMEDICS EXENDED MITRAL ROTATOR

    K Number: K951368 · Decision Jun 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    22
    Review Days
    85

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CARBOMEDICS EXENDED MITRAL ROTATOR
    K Number
    K951368
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.3935
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carbomedics, Inc.
    Date Received
    March 27, 1995
    Decision Date
    June 20, 1995
    Product Code
    MOP
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MOP Rotator, Prosthetic Heart Valve

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MOP), ordered by most recent decision date.

    MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    CARBOMEDICS MITRAL ROTATOR

    FDA 510(k)
    FDA Class 1 ·Cardiovascular
    View all

    Other Clearances by Carbomedics, Inc.

    K Number Device Name
    K970375 ANNULOFLO SYSTEM
    K964665 VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
    K962154 CARBOMEDICS HANDLE
    K960923 CARBOMEDICS MITRAL ROTATOR
    K960706 VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
    K960169 CARBOMEDICS VALVE TESTER
    K955588 VASCUTEK GRAFT SIZER SET
    K952184 CARBOMEDICS SUPRA-ANNULAR VALVE SIZER
    K942736 CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE
    K934951 VALVE SIZER
    Search all 22 clearances from Carbomedics, Inc. →