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

    HEPARIN PUMP

    K Number: K761050 · Decision Dec 30, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    45

    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
    HEPARIN PUMP
    K Number
    K761050
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Dws, Inc.
    Date Received
    November 15, 1976
    Decision Date
    December 30, 1976
    Product Code
    FIR
    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
    FIR Pump, Blood, Extra-Luminal

    Similar 510(k) Clearances

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

    ATI PLASMA PUMP (PP-04)

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

    INFUSION PUMP

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

    ASAHI BLOOD/PLASMA PUMP #ABP-01A &

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

    SPS-SINGLE PATIENT SYSTEM

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

    BLOOD PUMP-MODE S10K

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

    RS-7800 MINIPUMP

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

    Other Clearances by Dws, Inc.

    K Number Device Name
    K761051 BI-FLOW NEEDLE