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

    CMS IV EXTENSION SETS

    K Number: K884370 · Decision Nov 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    12
    Review Days
    20

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    Basic Information

    Device Name
    CMS IV EXTENSION SETS
    K Number
    K884370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Churchill Medical Systems, Inc.
    Date Received
    October 18, 1988
    Decision Date
    November 7, 1988
    Product Code
    FPK
    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
    FPK Tubing, Fluid Delivery

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    Other Clearances by Churchill Medical Systems, Inc.

    K Number Device Name
    K041038 CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
    K021395 MODIFICATION TO 30 EXTENSION SET
    K013949 UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
    K020544 WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
    K013950 VENTED VIAL ACCESS DEVICE
    K012157 CHURCHILL MEDICAL SYSTEMS STOPCOCK
    K011888 PRESSURE ACTIVATED CHECK VALVE
    K011336 PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
    K896333 CMS IV FILTERS
    K894954 .22 & 1.2 MICRON IV FILTERS
    Search all 12 clearances from Churchill Medical Systems, Inc. →