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

    FLEXMEDICS GUIDEWIRE

    K Number: K893626 · Decision Sep 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    20
    Review Days
    138

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    Basic Information

    Device Name
    FLEXMEDICS GUIDEWIRE
    K Number
    K893626
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Flexmedics
    Date Received
    May 11, 1989
    Decision Date
    September 26, 1989
    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 Flexmedics

    K Number Device Name
    K990765 FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO
    K964955 FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING
    K952430 FINESSE GUIDEWIRE CORONARY
    K943390 FLEXFINDER GUIDEWIRE
    K942074 FLEXFINDER GUIDEWIRE
    K934265 FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE
    K912843 FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE
    K910674 FLEXMEDICS MALLEABLE CANNULA
    K895899 FLEXMEDICS GUIDEWIRE .012 ONLY
    K885086 TIN COATED NITI ORTHODONTIC ARCH WIRES
    Search all 20 clearances from Flexmedics →