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

    OPTICATH HEPARIN COATED, FLOW-DIRECT

    K Number: K823007 · Decision Nov 1, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    12
    Review Days
    20

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    Basic Information

    Device Name
    OPTICATH HEPARIN COATED, FLOW-DIRECT
    K Number
    K823007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Oximetrix, Inc.
    Date Received
    October 12, 1982
    Decision Date
    November 1, 1982
    Product Code
    DYG
    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
    DYG Catheter, Flow Directed

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    Other Clearances by Oximetrix, Inc.

    K Number Device Name
    K853018 MODEL 3000 OPTICATH COMPUTER
    K842622 HEMO STATIC/ESU SCALPEL SYSTEM
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    K821056 FLOW DIRECTED THERMAL-DILUTION CATHETER
    K821057 FLOW DIRECTED THERMAL-DILUTION INFUSION
    K820674 OPTICATH
    K811391 OXIMETRIX ACCU SAT CPB
    K791868 OXIMETRIX SHAW HEMOSTATIC SURG. SYS.
    K781879 HEATER, OXIMETER SYSTEM
    K781134 CATHETER, THERMAL DILUTION FIBEROPTIC
    Search all 12 clearances from Oximetrix, Inc. →