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

    JMS BYPASS TUBE

    K Number: K032977 · Decision May 25, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    10
    Review Days
    244

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    Basic Information

    Device Name
    JMS BYPASS TUBE
    K Number
    K032977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jms North America Corp.
    Date Received
    September 24, 2003
    Decision Date
    May 25, 2004
    Product Code
    DWF
    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
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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    Other Clearances by Jms North America Corp.

    K Number Device Name
    K093637 JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300
    K082882 A.V. FISTULA BLUNT NEEDLE SET
    K070234 JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS
    K070143 JMS PLANECTA STOPCOCK
    K051814 JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
    K032975 JMS BLOOD TUBING SETS
    K040247 PLUME SAFETY AVF NEEDLE
    K030479 JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET
    K023668 JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR