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

    NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter

    K Number: K241540 · Decision Jun 28, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    73
    Review Days
    28

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    Basic Information

    Device Name
    NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter
    K Number
    K241540
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosense Webster, Inc.
    Date Received
    May 31, 2024
    Decision Date
    June 28, 2024
    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

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    Other Clearances by Biosense Webster, Inc.

    K Number Device Name
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    K230253 OPTRELL™ Mapping Catheter with TRUEref™ Technology
    K223766 NUVISION™ NAV Ultrasound Catheter
    K223733 CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4
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