BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER

    K Number: K901129 · Decision Mar 30, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    5
    Review Days
    18

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    Basic Information

    Device Name
    BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER
    K Number
    K901129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medevice, Inc.
    Date Received
    March 12, 1990
    Decision Date
    March 30, 1990
    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 Medevice, Inc.

    K Number Device Name
    K072550 SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301
    K920638 BIO-MATE PIC CATHETER
    K912856 MEDE-FLO I.V. EXTENSION SET
    K884969 BIO-MATE(TM) EPIDURAL CATHETER