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

    BETTER-TUBING

    K Number: K964205 · Decision Apr 8, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    9
    Review Days
    537

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    Basic Information

    Device Name
    BETTER-TUBING
    K Number
    K964205
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Circulatory Technology, Inc.
    Date Received
    October 18, 1996
    Decision Date
    April 8, 1998
    Product Code
    DWF
    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
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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    Other Clearances by Circulatory Technology, Inc.

    K Number Device Name
    K140321 INITARY BETTER BLADDER-PEDIATRIC
    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)
    K964337 BETTER-BLADDER (BB)
    K961594 BETTER-VENTER
    K941492 PRESSURE RELIEF VALVE
    K942933 PRESSURE INFUSION CUFF