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

    JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS

    K Number: K070234 · Decision May 22, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    37
    Applicant Total
    10
    Review Days
    126

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    Basic Information

    Device Name
    JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS
    K Number
    K070234
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jms North America Corp.
    Date Received
    January 16, 2007
    Decision Date
    May 22, 2007
    Product Code
    MPB
    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
    MPB Catheter, Hemodialysis, Non-Implanted

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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
    K070143 JMS PLANECTA STOPCOCK
    K051814 JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
    K032975 JMS BLOOD TUBING SETS
    K032977 JMS BYPASS TUBE
    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