BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCESS POINT TECHNOLOGIES, EP INC.

    Reg #: 3005402529 · FEI: 3005402529 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    ACCESS POINT TECHNOLOGIES, EP INC.
    Registration Number
    3005402529
    FEI Number
    3005402529
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12560 FLETCHER LANE, SUITE 300
    City
    Rogers
    State
    MN
    ZIP
    55374
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250590

    Owner / Operator

    Firm Name
    Stereotaxis
    Operator Number
    9048165
    Address
    710 N. Tucker Blvd., Suite 110
    City
    Saint Louis
    State
    MO
    Postal Code
    63101
    Country
    US
    Correspondent
    Angela McKnight

    Products

    Device Name Product Code
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Cable, Electrode IKD
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE

    Proprietary Names

    MAGiC Sweep EP Mapping Catheter Cable, Electrode Catheter, Electrode recording, or probe, electrode recording Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Device in the United States for Export Only