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

    RADIFOCUS GUIDE WIRE M

    K Number: K923607 · Decision Oct 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    143
    Review Days
    78

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    Basic Information

    Device Name
    RADIFOCUS GUIDE WIRE M
    K Number
    K923607
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Medical Corp.
    Date Received
    July 16, 1992
    Decision Date
    October 2, 1992
    Product Code
    KOD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOD Catheter, Urological

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    K082997 TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
    K090040 RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
    K082847 PINNACLE ROII INTRODUCER SHEATH
    K082519 FINECROSS MG CORONARY MICRO-GUIDE CATHETER
    K082736 RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
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