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

    BIPORE BALLOON DILATATION CATHETER

    K Number: K983650 · Decision Feb 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    10
    Review Days
    124

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    Basic Information

    Device Name
    BIPORE BALLOON DILATATION CATHETER
    K Number
    K983650
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bipore, Inc.
    Date Received
    October 16, 1998
    Decision Date
    February 17, 1999
    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 Bipore, Inc.

    K Number Device Name
    K073434 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
    K073318 BIPORE BALLOON DILATION CATHETER
    K051513 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
    K041293 BIOPORE BALLOON DILATION CATHETER
    K973563 BIPORE BALLOON DILATATION CATHETER
    K964814 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
    K961980 BIPORE BALLOON DILATATION CATHETER
    K862015 O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER
    K844625 BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY