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

    RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)

    K Number: K090040 · Decision Feb 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    143
    Review Days
    31

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    Basic Information

    Device Name
    RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
    K Number
    K090040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Medical Corp.
    Date Received
    January 6, 2009
    Decision Date
    February 6, 2009
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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 Terumo Medical Corp.

    K Number Device Name
    K111606 PINNACLE PRECISION ACCESS SYSTEM
    K111556 GLIDECROSS SUPPORT CATHETER
    K110540 TERUMO SUPPORT CATHETER
    K102008 GLIDESHEATH
    K091329 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
    K082997 TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
    K082847 PINNACLE ROII INTRODUCER SHEATH
    K082519 FINECROSS MG CORONARY MICRO-GUIDE CATHETER
    K082736 RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
    K082644 GLIDESHEATH
    Search all 143 clearances from Terumo Medical Corp. →