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

    Arrow Endurance Extended Dwell Peripheral Catheter System

    K Number: K152272 · Decision Nov 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    8
    Review Days
    103

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    Basic Information

    Device Name
    Arrow Endurance Extended Dwell Peripheral Catheter System
    K Number
    K152272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
    Date Received
    August 12, 2015
    Decision Date
    November 23, 2015
    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 Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

    K Number Device Name
    K180395 EZ-IO Intraosseous Vascular Access System
    K163513 Arrow Endurance Extended Dwell Peripheral Catheter System
    K161313 ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology
    K160018 Arrow Quickflash Arterial Catheterization Device
    K153487 CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
    K153423 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
    K143102 Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions