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

    Arrow Quickflash Arterial Catheterization Device

    K Number: K160018 · Decision Jun 13, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    8
    Review Days
    160

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Arrow Quickflash Arterial Catheterization Device
    K Number
    K160018
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
    Date Received
    January 5, 2016
    Decision Date
    June 13, 2016
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DQX), ordered by most recent decision date.

    InQwire Amplatz Guide Wire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Enroute 0.014'' Transcarotid Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EmeryGlide™ (EG18008901)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    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
    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
    K152272 Arrow Endurance Extended Dwell Peripheral Catheter System
    K143102 Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions