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

    SOFT VENOUS RESERVOIR

    K Number: K955046 · Decision Jan 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    75
    Review Days
    69

    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
    SOFT VENOUS RESERVOIR
    K Number
    K955046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gish Biomedical, Inc.
    Date Received
    November 3, 1995
    Decision Date
    January 11, 1996
    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 Gish Biomedical, Inc.

    K Number Device Name
    K090449 MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
    K090450 MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
    K091062 MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
    K083131 MEDOS HILITE RESERVOIR, MODEL: 4030
    K082403 MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
    K082082 GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
    K081947 GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
    K080708 VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
    K081838 GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
    K081881 GISH TUBING AND CONNECTORS WITH HA COATING
    Search all 75 clearances from Gish Biomedical, Inc. →