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

    NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

    K Number: K200195 · Decision Jun 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    147

    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
    NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
    K Number
    K200195
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Northeast Scientific, Inc.
    Date Received
    January 27, 2020
    Decision Date
    June 22, 2020
    Product Code
    OBJ
    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
    OBJ Catheter, Ultrasound, Intravascular

    Similar 510(k) Clearances

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

    Novasight Hybrid System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    XC11 ICE System, USA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™

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

    Other Clearances by Northeast Scientific, Inc.

    K Number Device Name
    K250592 NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
    K223026 NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
    K220171 NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
    K090661 NES REPROCESSED VARICOSE VEIN RF CATHETER
    K060676 NES REPROCESSED ENDOSCOPIC TROCAR