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

    JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET

    K Number: K030479 · Decision Aug 18, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    10
    Review Days
    186

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    Basic Information

    Device Name
    JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET
    K Number
    K030479
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jms North America Corp.
    Date Received
    February 13, 2003
    Decision Date
    August 18, 2003
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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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
    K032977 JMS BYPASS TUBE
    K040247 PLUME SAFETY AVF NEEDLE
    K023668 JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR