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

    CG+ ARROW JACC POWERED BY ARROW VPS STYLET

    K Number: K132133 · Decision Sep 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    77

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    Basic Information

    Device Name
    CG+ ARROW JACC POWERED BY ARROW VPS STYLET
    K Number
    K132133
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arrow International (Subsidiary of Teleflex Inc.)
    Date Received
    July 11, 2013
    Decision Date
    September 26, 2013
    Product Code
    OBJ
    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
    OBJ Catheter, Ultrasound, Intravascular

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

    K Number Device Name
    K122854 ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
    K121501 ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)
    K122545 CG+ ARROW PICC POWERED BY ARROW VPS STYLET
    K121941 ARROW PICC POWERED BY ARROW VPS STYLET
    K112896 ARRW EVOLUTION