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

    INITARY BETTER BLADDER-PEDIATRIC

    K Number: K140321 · Decision Apr 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    9
    Review Days
    58

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    Basic Information

    Device Name
    INITARY BETTER BLADDER-PEDIATRIC
    K Number
    K140321
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Circulatory Technology, Inc.
    Date Received
    February 18, 2014
    Decision Date
    April 17, 2014
    Product Code
    DTN
    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
    DTN Reservoir, Blood, Cardiopulmonary Bypass

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    Other Clearances by Circulatory Technology, Inc.

    K Number Device Name
    K012942 THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
    K001822 THE V-BAG
    K981284 BETTER-BLADDER (BB)
    K964205 BETTER-TUBING
    K964337 BETTER-BLADDER (BB)
    K961594 BETTER-VENTER
    K941492 PRESSURE RELIEF VALVE
    K942933 PRESSURE INFUSION CUFF