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

    CHURCHILL-H EXTENSION TUBE

    K Number: K854629 · Decision Dec 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    35
    Review Days
    22

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CHURCHILL-H EXTENSION TUBE
    K Number
    K854629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Churchill Corp.
    Date Received
    November 18, 1985
    Decision Date
    December 10, 1985
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FPK), ordered by most recent decision date.

    MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EMPOWER TRANSFER SET, (CAT. NO. 7725)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDRAD SWABBABLE VALVE TRANSFER SET

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Churchill Corp.

    K Number Device Name
    K880025 CHURCHILL 0.22 MICRON LIQUID FILTER SETS
    K880026 CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS
    K880051 ENTERAL BAG/SET
    K880027 CHURCHILL 1.2 MICRON LIQUID FILTER SET
    K872585 CHURCHILL-CATH
    K870395 CHURCHILL PARENTERAL NUTRITION BAG - EVA
    K872124 CHURCHILL ALBUMIN IV ADMINISTRATION SET
    K872123 CHURCHILL TPN ADMINISTRATION SET
    K872043 CHURCHILL INTER-CARDIAC SUCKER
    K871084 NITROGLYCERINE PUMP SET
    Search all 35 clearances from Churchill Corp. →