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

    IV FILTER EXTENSION SET

    K Number: K860803 · Decision Apr 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    97
    Applicant Total
    22
    Review Days
    36

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    Basic Information

    Device Name
    IV FILTER EXTENSION SET
    K Number
    K860803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Med Fusion Systems, Inc.
    Date Received
    March 4, 1986
    Decision Date
    April 9, 1986
    Product Code
    FPB
    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
    FPB Filter, Infusion Line

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    Other Clearances by Med Fusion Systems, Inc.

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    K870907 INTRODUCER, PERCUTANEOUS
    K864407 REFILLABLE SYRINGE
    K863814 BAG SPIKE EXTENSION SET
    K860616 VOLUME CONTROL SET WITH EXTENSION
    K844313 INFUSET W/HUBER NEEDLE
    K842984 EXTENSION SET W/INJECTION SITE
    K842143 BENT WINGED MINI-VOL INFUSION SET
    K841882 THREE WAY INFUSION SET
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