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

    THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

    K Number: K101422 · Decision Mar 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    8
    Review Days
    306

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    Basic Information

    Device Name
    THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
    K Number
    K101422
    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, Inc.
    Date Received
    May 20, 2010
    Decision Date
    March 22, 2011
    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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    K111138 THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
    K101150 PICC WAND PEELABLE SAFETY INTRODUCER
    K093022 THE PICC WAND PEELABLE SAFETY INTRODUCER
    K090372 THE WAND MICROACCESS SAFETY INTRODUCER
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