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

    EXTENSION SETS

    K Number: K864692 · Decision Dec 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    8
    Review Days
    16

    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
    EXTENSION SETS
    K Number
    K864692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Salt Creek Medical Technologies
    Date Received
    December 2, 1986
    Decision Date
    December 18, 1986
    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 Salt Creek Medical Technologies

    K Number Device Name
    K864683 NEONATAL FEEDING KIT
    K871042 URINE METER, 250CC
    K871075 SCMT UMBILICAL CLAMP
    K871087 S.C.M.T. PERFORATOR
    K864296 S.C.T. MULTI PORT, INJECTION SITE
    K864682 SALT CREEK P.I. TRAY
    K864693 I.V. START KITS