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

    CYTORI CELUTION CELL CONCENTRATION DEVICE

    K Number: K060482 · Decision Sep 28, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    6
    Review Days
    217

    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
    CYTORI CELUTION CELL CONCENTRATION DEVICE
    K Number
    K060482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cytori Therapeutics, Inc.
    Date Received
    February 23, 2006
    Decision Date
    September 28, 2006
    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 Cytori Therapeutics, Inc.

    K Number Device Name
    K132815 PUREGRAFT 50 SYSTEM
    K113255 PUREGRAFT 850/PURE SYSTEM
    K092923 CYTORI PUREGRAFT 250/PURE SYSTEM
    K072587 CYTORI AFT SYSTEM
    K063235 CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT