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

    SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE

    K Number: K872472 · Decision Sep 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    8
    Review Days
    83

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    Basic Information

    Device Name
    SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE
    K Number
    K872472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Angiomedics, Inc.
    Date Received
    June 23, 1987
    Decision Date
    September 14, 1987
    Product Code
    DXT
    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
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Angiomedics, Inc.

    K Number Device Name
    K873195 SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO
    K872542 SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER
    K863342 SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER
    K861238 ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV
    K852872 ANGIOMEDICS SOFTIP CATHETER
    K850271 ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR
    K834275 SOFTIP CATHETER