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

    I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-

    K Number: K830755 · Decision Apr 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    6
    Review Days
    49

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    Basic Information

    Device Name
    I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-
    K Number
    K830755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medical Parameters, Inc.
    Date Received
    March 10, 1983
    Decision Date
    April 28, 1983
    Product Code
    FPA
    Advisory Committee
    General Hospital
    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
    FPA Set, Administration, Intravascular

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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
    K831239 WALRUS PERCUTANEOUS INTRODUCER SET