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

    TFX MEDICAL GUIDEWIRE

    K Number: K963320 · Decision Dec 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    3
    Review Days
    102

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    Basic Information

    Device Name
    TFX MEDICAL GUIDEWIRE
    K Number
    K963320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tfx Medical Group
    Date Received
    August 23, 1996
    Decision Date
    December 3, 1996
    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 Tfx Medical Group

    K Number Device Name
    K992664 TFX MEDICAL STYLET CATHETER
    K991647 TFX MEDICAL INTRODUCER KIT