BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Nipro Vascular Innovations Americas, Inc.

    Reg #: 3015551113 · FEI: 3015551113 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Nipro Vascular Innovations Americas, Inc.
    Registration Number
    3015551113
    FEI Number
    3015551113
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    28 Crosby Drive, Suite 100
    City
    Bedford
    State
    MA
    ZIP
    01730
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241576

    Owner / Operator

    Firm Name
    Nipro Vascular Innovations Americas, Inc.
    Operator Number
    10025766
    Address
    28 Crosby Drive, Suite 100
    City
    Bedford
    State
    MA
    Postal Code
    01730
    Country
    US
    Correspondent
    Nozomi Yagi

    Products

    Device Name Product Code
    Catheter, Ultrasound, Intravascular OBJ
    Catheter, Intravascular, Plaque Morphology Evaluation OGZ
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42) Makoto Intravascular Imaging System™ (TVC-MC10/TVC-MC10i) Clarispro™ HD-IVUS Imaging Catheter (TVC-E195-42)

    Establishment Types

    Manufacture Medical Device