BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK

    K Number: K102648 · Decision Jul 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    56
    Applicant Total
    4
    Review Days
    290

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    Basic Information

    Device Name
    ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK
    K Number
    K102648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Ant Hi-Tech Industrial Co., Ltd.
    Date Received
    September 14, 2010
    Decision Date
    July 1, 2011
    Product Code
    MAV
    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
    MAV Syringe, Balloon Inflation

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    Other Clearances by Shenzhen Ant Hi-Tech Industrial Co., Ltd.

    K Number Device Name
    K131770 PRESSURE CONNECTING TUBE
    K091408 DISPOSABLE PRESSURE TRANSDUCER
    K072696 ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301