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

    ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)

    K Number: K121501 · Decision Nov 29, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    6
    Review Days
    192

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    Basic Information

    Device Name
    ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)
    K Number
    K121501
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arrow International (Subsidiary of Teleflex Inc.)
    Date Received
    May 21, 2012
    Decision Date
    November 29, 2012
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Arrow International (Subsidiary of Teleflex Inc.)

    K Number Device Name
    K132133 CG+ ARROW JACC POWERED BY ARROW VPS STYLET
    K122854 ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
    K122545 CG+ ARROW PICC POWERED BY ARROW VPS STYLET
    K121941 ARROW PICC POWERED BY ARROW VPS STYLET
    K112896 ARRW EVOLUTION