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

    BIOTEQ ANGIOGRAPHIC CATHETER

    K Number: K102633 · Decision Sep 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    11
    Review Days
    361

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    Basic Information

    Device Name
    BIOTEQ ANGIOGRAPHIC CATHETER
    K Number
    K102633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bioteque Corp.
    Date Received
    September 13, 2010
    Decision Date
    September 9, 2011
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Bioteque Corp.

    K Number Device Name
    K150932 Sheath Introducer
    K033862 BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK
    K033210 BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET
    K032292 BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
    K013634 BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
    K012526 BIOTEQUE SCALP VEIN SET
    K002449 BIOTEQ I.V. (INTRAVENOUS) SET
    K992930 BIOTEQUE HEMODIALYSIS BLOOD TUBING SET
    K993118 BIOTEQUE A.V. FISTULA NEEDLE SET
    K915491 CURELLE
    Search all 11 clearances from Bioteque Corp. →