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

    TERUMO GAS FILTER

    K Number: K021020 · Decision Jun 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    43
    Review Days
    73

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    Basic Information

    Device Name
    TERUMO GAS FILTER
    K Number
    K021020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Cardiovascular Systems Corp.
    Date Received
    March 29, 2002
    Decision Date
    June 10, 2002
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAH Filter, Bacterial, Breathing-Circuit

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    K133658 CDI BLOOD PARAMETER MONITORING SYSTEM 500
    K131041 ADVANCED PERFUSION SYSTEM 1
    K132451 SARNS SOFT-FLOW AORTIC CANNULA
    K133151 SARNS HIGH FLOW AORTIC ARCH CANNULA
    K130333 CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
    K130359 CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
    K123039 CDI BLOOD PARAMETER MONITORING SYSTEM 500
    K113214 TLINK DATA MANAGEMENT SYSTEM (DMS)
    K112587 ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
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