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

    SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES

    K Number: K944677 · Decision Feb 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    8
    Review Days
    139

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    Basic Information

    Device Name
    SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES
    K Number
    K944677
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scimed Peripheral Interventions
    Date Received
    September 22, 1994
    Decision Date
    February 8, 1995
    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 Peripheral Interventions

    K Number Device Name
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    K941710 SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIES
    K935501 SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING
    K934793 SCIMED MAVERICK
    K934359 SCIMED STRIKE STEERABLE GUIDE WIRE
    K934122 SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES