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

    THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL

    K Number: K121748 · Decision Jul 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    8
    Review Days
    43

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    Basic Information

    Device Name
    THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL
    K Number
    K121748
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Access Scientific, Inc.
    Date Received
    June 14, 2012
    Decision Date
    July 27, 2012
    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, Inc.

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    K101422 THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
    K101150 PICC WAND PEELABLE SAFETY INTRODUCER
    K093022 THE PICC WAND PEELABLE SAFETY INTRODUCER
    K090372 THE WAND MICROACCESS SAFETY INTRODUCER
    K081697 THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006