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

    DIDECO ELECTA

    K Number: K020647 · Decision Sep 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    22
    Review Days
    189

    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
    DIDECO ELECTA
    K Number
    K020647
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dideco S.P.A.
    Date Received
    February 28, 2002
    Decision Date
    September 5, 2002
    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 Dideco S.P.A.

    K Number Device Name
    K041061 D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
    K033323 D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING
    K033987 D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
    K033714 MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
    K032040 IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
    K031223 SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
    K030154 IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
    K021732 DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT
    K022450 INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
    K020997 APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
    Search all 22 clearances from Dideco S.P.A. →