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

    ACS ANGIOSCOPE GUIDE WIRE

    K Number: K883000 · Decision Sep 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    40
    Applicant Total
    103
    Review Days
    72

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    Basic Information

    Device Name
    ACS ANGIOSCOPE GUIDE WIRE
    K Number
    K883000
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Cardiovascular Systems, Inc.
    Date Received
    July 18, 1988
    Decision Date
    September 28, 1988
    Product Code
    LYK
    Advisory Committee
    Gastroenterology, Urology
    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
    LYK Angioscope

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    K962495 INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
    K961471 INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
    K955175 ACS ANCHOR EXCHANGE DEVICE
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