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

    CAPIOX CR-CARDIOTOMY RESERVOIR

    K Number: K821538 · Decision Aug 6, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    33
    Applicant Total
    143
    Review Days
    74

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    Basic Information

    Device Name
    CAPIOX CR-CARDIOTOMY RESERVOIR
    K Number
    K821538
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Terumo Medical Corp.
    Date Received
    May 24, 1982
    Decision Date
    August 6, 1982
    Product Code
    DTP
    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
    DTP Defoamer, Cardiopulmonary Bypass

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    Other Clearances by Terumo Medical Corp.

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    K082997 TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
    K090040 RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
    K082847 PINNACLE ROII INTRODUCER SHEATH
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