BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP

    K Number: K112372 · Decision Sep 15, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    161
    Applicant Total
    2
    Review Days
    29

    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
    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
    K Number
    K112372
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3535
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiac Assist, Maquet Cardiovascular, LLC
    Date Received
    August 17, 2011
    Decision Date
    September 15, 2011
    Product Code
    DSP
    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
    DSP System, Balloon, Intra-Aortic And Control

    Similar 510(k) Clearances

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

    AC3™ Range™ Intra-Aortic Balloon Pump

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AC3™ Series IABP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AC3 Series Intra-Aortic Balloon Pump (IABP)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UltraFlex IAB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Cardiac Assist, Maquet Cardiovascular, LLC

    K Number Device Name
    K112327 SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES