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

    THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101

    K Number: K831424 · Decision Oct 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    69
    Review Days
    164

    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
    THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
    K Number
    K831424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    May 3, 1983
    Decision Date
    October 14, 1983
    Product Code
    FJK
    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
    FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

    Similar 510(k) Clearances

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

    NovaLine Tubing Set for Hemodialysis (BL 124)

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

    VITAL Tubing Sets for Hemodialysis

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

    TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

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

    Moda-flx Hemodialysis System™ Cartridge (102121-001 )

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

    CombiSet Hemodialysis Blood Tubing Set

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

    Tablo Cartridge

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

    Other Clearances by Extracorporeal Medical Specialities, Inc.

    K Number Device Name
    K843955 EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
    K840532 HEMOPERFUSION SYSTEM TP-400
    K840262 HANCOCK PERICARDIAL PATCH
    K840146 EXP* 700 PARALLEL PLATE DIALYZER
    K840057 EXP* 500 PARALLEL PLATE DIALYZER
    K831423 THERAPEUTIC EXCHANGE SYSTEM
    K832547 ULTRAFILTRATION CONTROLLER
    K833477 INTERSEPT 40 MICRON FILTER
    K833476 INTERSEPT 40 MICRON FILTER W/TUBING
    K832053 SINGLE PATIENT SYS. II MODEL DM-450
    Search all 69 clearances from Extracorporeal Medical Specialities, Inc. →