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

    CHARGED SUPOR(R) FILTER EXTENSION SET

    K Number: K940980 · Decision Jul 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    97
    Applicant Total
    19
    Review Days
    135

    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
    CHARGED SUPOR(R) FILTER EXTENSION SET
    K Number
    K940980
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B. Braun of America, Inc.
    Date Received
    March 1, 1994
    Decision Date
    July 14, 1994
    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 B. Braun of America, Inc.

    K Number Device Name
    K993024 CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
    K983794 CHEMO MINI SPIKE PLUS
    K946170 COMFORT-Q SUBCUTANEOUS INJECTION SETS
    K945850 BRAUN DIACAN(R) FISTULA NEEDLES
    K942988 FILTERED EXTENSION SETS
    K945752 CELSITE(TM) BRACHIAL VENOUS PORT
    K945551 CELSITE(TM) DUAL VENOUS SYSTEM
    K943770 LOW VOLUME MULTIPORT
    K950982 B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
    K950184 B. BRAUN IV START KITS
    Search all 19 clearances from B. Braun of America, Inc. →