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

    PTA-DUO PTA BALLOON CATHETER

    K Number: K101047 · Decision Jul 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    PTA-DUO PTA BALLOON CATHETER
    K Number
    K101047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hotspur Technologies
    Date Received
    April 14, 2010
    Decision Date
    July 13, 2010
    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 Hotspur Technologies

    K Number Device Name
    K130397 ARROW GPSCATH BALLOON DILATATION CATHETER
    K113769 GPSCATH BALLON DILATATION CATHETER
    K100842 PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
    K100840 EMBO PLUS EMBOLECTOMY CATHETER