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

    DIALYSIS ADMINISTRATION KITS

    K Number: K952572 · Decision Jan 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    149
    Review Days
    220

    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
    DIALYSIS ADMINISTRATION KITS
    K Number
    K952572
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B.Braun Medical, Inc.
    Date Received
    June 5, 1995
    Decision Date
    January 11, 1996
    Product Code
    KOC
    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
    KOC Accessories, Blood Circuit, Hemodialysis

    Similar 510(k) Clearances

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

    BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)

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

    BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU

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

    Blood Tubing Lines for Hemodialysis AV06C-E

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

    Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series

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

    CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line

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

    CAREline Airless Hemodialysis Blood Tubing Sets

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

    Other Clearances by B.Braun Medical, Inc.

    K Number Device Name
    K253235 Introcan Safety® Deep Access XL IV Catheter
    K243392 Infusomat® Space Volumetric Infusion Pump Administration Sets
    K240578 VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
    K241845 Introcan Safety® 2 IV Catheter
    K241385 Omnifix Syringe NRFit
    K231242 Perifix FX Catheter; Contiplex FX Catheter
    K223479 AQUAbase nX
    K220756 Introcan Safety 2 IV Catheter
    K220626 Introcan Safety IV Catheter
    K213778 IV Administration Set
    Search all 149 clearances from B.Braun Medical, Inc. →