BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VIVO System

    Reg #: 3010728615 · FEI: 3010728615 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Catheter Precision, Incorporated
    Registration Number
    3010728615
    FEI Number
    3010728615
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1670 Highway 160 West, Suite 205
    City
    Fort Mill
    State
    SC
    ZIP
    29708
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183195

    Owner / Operator

    Firm Name
    Catheter Precision
    Operator Number
    10031997
    Address
    1607 Highway 160, Suite 205
    City
    Fort Mill
    State
    SC
    Postal Code
    29708
    Country
    US
    Correspondent
    Darci Diage

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    VIVO System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device