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

    VAN DELLEN BACTERIA FILTER

    K Number: K873465 · Decision Jan 20, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    7
    Review Days
    145

    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
    VAN DELLEN BACTERIA FILTER
    K Number
    K873465
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Van Dellen, Ltd.
    Date Received
    August 28, 1987
    Decision Date
    January 20, 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

    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 Van Dellen, Ltd.

    K Number Device Name
    K873463 VAN DELLEN ASPIRATING TUBING
    K873464 VAN DELLEN CANNULA
    K873462 VAN DELLEN ASPIRATOR
    K873162 VAN DELLEN RETROBULBAR NEEDLE
    K873163 VAN DELLEN IRRIGATING CYSTOTOME
    K873164 VAN DELLEN HEALON CANNULA