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

    SLIDEWIRETM(TRADEMARK PENDING)

    K Number: K113162 · Decision Jul 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    5
    Review Days
    268

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    Basic Information

    Device Name
    SLIDEWIRETM(TRADEMARK PENDING)
    K Number
    K113162
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acme-Monaco Corp.
    Date Received
    October 26, 2011
    Decision Date
    July 20, 2012
    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

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    Other Clearances by Acme-Monaco Corp.

    K Number Device Name
    K920884 GUIDEWIRES, VARIOUS TYPES
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    K895483 ACME COATED ORTHODONTIC ARCHWIRE
    K883763 ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH