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

    CONCORD/PORTEX EPIDURAL CATHETERS

    K Number: K935927 · Decision Sep 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    22
    Review Days
    270

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    Basic Information

    Device Name
    CONCORD/PORTEX EPIDURAL CATHETERS
    K Number
    K935927
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smiths Industries Medical Systems, Inc.
    Date Received
    December 13, 1993
    Decision Date
    September 9, 1994
    Product Code
    BSO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BSO Catheter, Conduction, Anesthetic

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    Other Clearances by Smiths Industries Medical Systems, Inc.

    K Number Device Name
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    K962175 PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
    K962931 SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
    K963570 SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
    K960429 PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
    K953485 SIMS CPAP SYSTEM
    K953483 SIMS BLUE LINE ENDOBRONCHIAL TUBE
    K932946 WALLACE IV CANNULA
    K932947 WALLACE Y-CAN
    Search all 22 clearances from Smiths Industries Medical Systems, Inc. →