BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IBI-1100 Bi-Directional Steerable Electrophysiology Catheter System

    Reg #: 2030404 · FEI: 1000519796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    IRVINE BIOMEDICAL. INC.
    Registration Number
    2030404
    FEI Number
    1000519796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2375 Morse Ave
    City
    IRVINE
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K982232

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF

    Proprietary Names

    IBI-1100 Bi-Directional Steerable Electrophysiology Catheter System Inquiry™ Steerable Diagnostic Catheter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device