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

    MS CLASSIQUE BALLOON CATHETER

    K Number: K944143 · Decision Mar 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    24
    Review Days
    200

    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
    MS CLASSIQUE BALLOON CATHETER
    K Number
    K944143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meadox Surgimed, Inc.
    Date Received
    August 25, 1994
    Decision Date
    March 13, 1995
    Product Code
    FGE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FGE Stents, Drains And Dilators For The Biliary Ducts

    Similar 510(k) Clearances

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

    Dilation Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Endoflux™ Biliary & Pancreatic Stent Sets

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BARE Wireguided Balloon Dilation Catheter (1235)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single use stone retrieval balloons

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Niti-S Biliary Stent; Niti-S Biliary Slim M Stent

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Meadox Surgimed, Inc.

    K Number Device Name
    K945061 NOPROFILE OLBERT CATHETER SYSTEM
    K942382 MS AMPLATZ EXTRA STIFF GUIDE WIRE
    K930201 ACECUT SUTOMATIC BIOPSY SYSTEM
    K911635 MEADOX(R) SURGIMED(R) BIOPSY GUN II
    K905181 NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY
    K904582 QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE
    K904983 MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY
    K902461 MEADOX SURGIMED BIOPSY GUN AND NEEDLE
    K890926 SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE
    K863218 CYTOSTATIC FILTRATION SET
    Search all 24 clearances from Meadox Surgimed, Inc. →