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

    SMARTWIRE/SMARTMAP PRESSURE SYSTEM

    K Number: K021219 · Decision May 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    SMARTWIRE/SMARTMAP PRESSURE SYSTEM
    K Number
    K021219
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jomed, Inc.
    Date Received
    April 17, 2002
    Decision Date
    May 17, 2002
    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 Jomed, Inc.

    K Number Device Name
    K031346 JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
    K031148 IN-VISION IMAGING SYSTEM
    K031277 JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
    K022762 JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050
    K003938 TRAK BACK II