BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    SAFE-1 VENOUS RESERVOIR

    K Number: K893705 · Decision Dec 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    8
    Review Days
    218

    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
    SAFE-1 VENOUS RESERVOIR
    K Number
    K893705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Polystan C/O Vitalcor, Inc.
    Date Received
    May 18, 1989
    Decision Date
    December 22, 1989
    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 Polystan C/O Vitalcor, Inc.

    K Number Device Name
    K894657 POLYSTAN HEART-LUNG MACHINE SYSTEM
    K893940 POLYSTAN HEATER-COOLER UNIT
    K893704 SAFE-1
    K874853 POLYSTAN TWO STAGE CATHETERS
    K874852 POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS
    K872182 POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE
    K843538 PO 2 LYTRODE