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

    ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH.

    K Number: K903582 · Decision Nov 6, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH.
    K Number
    K903582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Catheter Sciences Co.
    Date Received
    August 8, 1990
    Decision Date
    November 6, 1990
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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    Other Clearances by Catheter Sciences Co.

    K Number Device Name
    K910965 ECHOMARK CSI INTERFACE