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

    CAROTID BYPASS SHUNT WITH SAMPLING ARM

    K Number: K860743 · Decision May 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    8
    Review Days
    90

    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
    CAROTID BYPASS SHUNT WITH SAMPLING ARM
    K Number
    K860743
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Clincal Instruments Corp.
    Date Received
    February 27, 1986
    Decision Date
    May 28, 1986
    Product Code
    DWF
    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
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Venous Return Cannulae

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Retrograde Coronary Sinus Perfusion Cannulae

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Dual Stage Venous Cannulae

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Clearview Intracoronary Shunts

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

    Other Clearances by Clincal Instruments Corp.

    K Number Device Name
    K902327 EMBOLECTOMY CATHETER
    K860742 CAROTID BYPASS SHUNT
    K852704 TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT
    K844918 OCCLUSION & OCCLUSION-IRRIGATION
    K821220 MULTILUMEN INTRAVENOUS INFUSION CATHETER
    K790034 INTRODUCERS
    K771043 SWAN GANZ