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

    COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR

    K Number: K963518 · Decision Dec 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    43
    Review Days
    461

    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
    COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR
    K Number
    K963518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cobe Cardiovascular, Inc.
    Date Received
    September 3, 1996
    Decision Date
    December 8, 1997
    Product Code
    DTZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DTZ Oxygenator, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    Lifemotion Disposable Membrane Oxygenator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)

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

    Other Clearances by Cobe Cardiovascular, Inc.

    K Number Device Name
    K050111 SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
    K042473 COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
    K040184 DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
    K033641 SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
    K030462 COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
    K021830 SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
    K011835 COBE REVOLUTION
    K013480 COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
    K012763 SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
    K001509 STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
    Search all 43 clearances from Cobe Cardiovascular, Inc. →