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

    WALRUS PERCUTANEOUS INTRODUCER SET

    K Number: K831239 · Decision May 25, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    40

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    Basic Information

    Device Name
    WALRUS PERCUTANEOUS INTRODUCER SET
    K Number
    K831239
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Medical Parameters, Inc.
    Date Received
    April 15, 1983
    Decision Date
    May 25, 1983
    Product Code
    DOY
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DOY Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.

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    Other Clearances by Medical Parameters, Inc.

    K Number Device Name
    K862190 WALRUS: DOUBLE BALLOON SHUNTING CATHETER
    K844444 ESOPHAGEAL STETHOSCOPE
    K833825 MULTI-LUMEN INTRAVENOUS INFUSION CATH
    K830754 BLOOD PRESSURE MONITORING KITS,WALRUS
    K830755 I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-