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

    The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model

    K Number: K183066 · Decision Jul 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    6
    Review Days
    262

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    Basic Information

    Device Name
    The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model
    K Number
    K183066
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Access Scientific, LLC
    Date Received
    November 5, 2018
    Decision Date
    July 25, 2019
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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    Other Clearances by Access Scientific, LLC

    K Number Device Name
    K181563 The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
    K182243 The CVC WAND Safety Introducer with Valved Peelable Sheath
    K162322 the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
    K131148 THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
    K131300 THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER