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

    TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET

    K Number: K910558 · Decision Aug 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    143
    Review Days
    180

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    Basic Information

    Device Name
    TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET
    K Number
    K910558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Terumo Medical Corp.
    Date Received
    February 8, 1991
    Decision Date
    August 7, 1991
    Product Code
    FJK
    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
    FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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    Other Clearances by Terumo Medical Corp.

    K Number Device Name
    K111606 PINNACLE PRECISION ACCESS SYSTEM
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    K110540 TERUMO SUPPORT CATHETER
    K102008 GLIDESHEATH
    K091329 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
    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
    Search all 143 clearances from Terumo Medical Corp. →