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

    1.2 MICRON FILTER WITH IV SET

    K Number: K896292 · Decision Dec 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    97
    Applicant Total
    13
    Review Days
    38

    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
    1.2 MICRON FILTER WITH IV SET
    K Number
    K896292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Kendall Mcgaw Laboratories, Inc.
    Date Received
    October 31, 1989
    Decision Date
    December 8, 1989
    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

    Similar 510(k) Clearances

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

    Filter Needle for Single Use

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Cathivex ¿GV filter units

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ARTERIA BLOOD FILTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PALL SUPOR AEF FILTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    0.2 U BACTERIAL FILTER

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

    Other Clearances by Kendall Mcgaw Laboratories, Inc.

    K Number Device Name
    K905610 MICRORATE INTELLIGENT PUMP
    K905611 MICRORATE PLUS INTELLIGENT PUMP
    K904855 ADD-A-VIAL
    K904518 VOLUMETRIC INFUSION PUMP
    K903809 PROTECTED NEEDLE WITH OR WITHOUT IV SET
    K901065 INFUSION PUMP
    K900865 ADD-A-VIAL II BINARY CONNECTOR
    K895109 SECONDARY IV SET WITH PROTECTED NEEDLE
    K882159 522 INTELLIGENT PUMP
    K874467 SET, ADMINISTRATION INTRAVASCULAR
    Search all 13 clearances from Kendall Mcgaw Laboratories, Inc. →