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

    PRESSURE RELIEF VALVE

    K Number: K941492 · Decision Oct 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    9
    Review Days
    212

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    Basic Information

    Device Name
    PRESSURE RELIEF VALVE
    K Number
    K941492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Circulatory Technology, Inc.
    Date Received
    March 28, 1994
    Decision Date
    October 26, 1994
    Product Code
    MNJ
    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
    MNJ Valve, Pressure Relief, 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)
    K964205 BETTER-TUBING
    K964337 BETTER-BLADDER (BB)
    K961594 BETTER-VENTER
    K942933 PRESSURE INFUSION CUFF