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

    SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER

    K Number: K863342 · Decision Mar 3, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    8
    Review Days
    187

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    Basic Information

    Device Name
    SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER
    K Number
    K863342
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Angiomedics, Inc.
    Date Received
    August 28, 1986
    Decision Date
    March 3, 1987
    Product Code
    DWF
    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
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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    Other Clearances by Angiomedics, Inc.

    K Number Device Name
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    K872542 SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER
    K872472 SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE
    K861238 ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV
    K852872 ANGIOMEDICS SOFTIP CATHETER
    K850271 ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR
    K834275 SOFTIP CATHETER