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

    CVIS ULTRA-SCAN ONE IMAGING CATHETER

    K Number: K893837 · Decision Aug 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    19
    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
    CVIS ULTRA-SCAN ONE IMAGING CATHETER
    K Number
    K893837
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Imaging Systems, Inc.
    Date Received
    May 24, 1989
    Decision Date
    August 22, 1989
    Product Code
    IYO
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IYO System, Imaging, Pulsed Echo, Ultrasonic

    Similar 510(k) Clearances

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

    ARTHUR

    FDA 510(k)
    FDA Class 2 ·Radiology

    EdgeFlow UW20

    FDA 510(k)
    FDA Class 2 ·Radiology

    Accuro XV

    FDA 510(k)
    FDA Class 2 ·Radiology

    QT Scanner 2000 Model A

    FDA 510(k)
    FDA Class 2 ·Radiology

    IntraSight Plus

    FDA 510(k)
    FDA Class 2 ·Radiology

    Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)

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

    Other Clearances by Cardiovascular Imaging Systems, Inc.

    K Number Device Name
    K970049 BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/
    K942231 MICROVIEW II/MICRORAIL II CATHETERS
    K933517 AUTOMATIC PULL BACK DEVICE
    K930232 CVIS INSIGHT IMAGING GUIDE CATHETER
    K924922 CVIS INSIGHT IMAGING CATHETER
    K930311 CVIS LONGVIEW
    K921879 CBIS CATHETER PULL-BACK DEVICE
    K921750 CVIS INSIGHT III SYSTEM
    K921631 CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL
    K921148 CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE
    Search all 19 clearances from Cardiovascular Imaging Systems, Inc. →