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

    SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE

    K Number: K960657 · Decision Apr 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    109
    Review Days
    73

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    Basic Information

    Device Name
    SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE
    K Number
    K960657
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scimed Life Systems, Inc.
    Date Received
    February 16, 1996
    Decision Date
    April 29, 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 Scimed Life Systems, Inc.

    K Number Device Name
    K974241 SCIMED INFORMER PRESSURE WIRE SYSTEM
    K981788 SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
    K980360 SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES
    K974559 SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
    K974684 SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER
    K973945 LUGE GUIDE WIRE
    K970823 SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER
    K964551 CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID
    K970244 SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES
    K965023 CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
    Search all 109 clearances from Scimed Life Systems, Inc. →