BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING

    K Number: K090690 · Decision Dec 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    44
    Review Days
    282

    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
    VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
    K Number
    K090690
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maquet Cardiopulmonary, AG
    Date Received
    March 16, 2009
    Decision Date
    December 23, 2009
    Product Code
    DTN
    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
    DTN Reservoir, Blood, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    Inspire HCR and HCR DUAL cardiotomy reservoirs

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Perfusion Hybrid System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BMR 1900 PHISIO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C

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

    Other Clearances by Maquet Cardiopulmonary, AG

    K Number Device Name
    K150267 QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
    K140569 ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
    K141432 NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
    K133598 CARDIOHELP SYSTEM
    K133265 QUADROX-IR ADULT AND SMALL ADULT
    K132166 VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
    K132829 QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
    K131666 ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
    K130300 HEATER-COOLER UNIT HCU 40
    K123288 HEMOCONCENTRATOR
    Search all 44 clearances from Maquet Cardiopulmonary, AG →