BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IMRICOR MEDICAL SYSTEMS

    Reg #: 3009254201 · FEI: 3009254201 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    IMRICOR MEDICAL SYSTEMS
    Registration Number
    3009254201
    FEI Number
    3009254201
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    400 Gateway Blvd
    City
    Burnsville
    State
    MN
    ZIP
    55337
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252164

    Owner / Operator

    Firm Name
    Imricor Medical Systems
    Operator Number
    10095474
    Address
    400 Gateway Blvd
    City
    Burnsville
    State
    MN
    Postal Code
    55337
    Country
    US
    Correspondent
    Oksana Alswager

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF

    Proprietary Names

    NorthStar™ Mapping System Vision-MR® Diagnostic Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device