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

    Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

    K Number: K181042 · Decision May 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    231
    Review Days
    28

    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
    Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
    K Number
    K181042
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corporation
    Date Received
    April 19, 2018
    Decision Date
    May 17, 2018
    Product Code
    DXK
    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
    DXK Echocardiograph

    Similar 510(k) Clearances

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

    Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IN-VISION IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9750 ATHENA ETHERNET OPTION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESSORY TO GENESIS III (GCFM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST

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

    Other Clearances by Boston Scientific Corporation

    K Number Device Name
    K260428 RIVOS™ EUS Access Device (M00553900)
    K260100 MOSES Raydar™
    K260771 TruSelect™ 2.6 Microcatheter
    K251273 Asurys Fluid Management System
    K260479 TheraSphere 360™ Y-90 Management Platform
    K260119 SpaceOAR Vue System (SV-2101)
    K252529 Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)
    K253376 OBSIDIO™ Conformable Embolic (M0013972101010)
    K252547 TheraSphere 360™ Y-90 Management Platform
    K252921 Radial Jaw 4 Pulmonary Biopsy Forceps
    Search all 231 clearances from Boston Scientific Corporation →