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

    ACU-MED RED MISER HEMOTHORAX BLOOD COLL.

    K Number: K791891 · Decision Dec 5, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    8
    Review Days
    71

    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
    ACU-MED RED MISER HEMOTHORAX BLOOD COLL.
    K Number
    K791891
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Acumed Instruments Corp.
    Date Received
    September 25, 1979
    Decision Date
    December 5, 1979
    Product Code
    CAC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAC Apparatus, Autotransfusion

    Similar 510(k) Clearances

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

    XTRA Collection sets; XTRA Sequestration set X

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Aventus Clot Management System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    XTRA Autotransfusion System (with XTRA Bowl sets)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FlowSaver Blood Return System (80-101)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FlowSaver Blood Return System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Acumed Instruments Corp.

    K Number Device Name
    K863627 MICRO SURGICAL DRILL SYSTEM
    K853660 MICRO SURGICAL DRILL SYSTEM
    K853658 BURS FOR MICRO SURGICAL DRILL SYSTEM
    K853659 POWERED IRRIGATION FOR MICRO SURGICAL DRILL
    K791399 ACU-ALERT
    K791400 GASTRIC LAVAGE KIT-DISPOSABLE
    K790901 I.V. TUBING ORGANIZER