BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Boston Scientific Cardiac Diagnostic Technologies, Inc.

    Reg #: 3009883402 · FEI: 3009883402 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    0
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    Boston Scientific Cardiac Diagnostic Technologies, Inc.
    Registration Number
    3009883402
    FEI Number
    3009883402
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2900 37th Street NW, Building 003
    City
    ROCHESTER
    State
    MN
    ZIP
    55901
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243349

    Owner / Operator

    Firm Name
    Boston Scientific Corporation
    Operator Number
    9912058
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US
    Correspondent
    Adrienne Bishop

    Products

    Device Name Product Code
    Outpatient Cardiac Telemetry QYX
    Detector And Alarm, Arrhythmia DSI
    Electrode, Electrocardiograph DRX
    Electrode, Electrocardiograph, Multi-Function MLN

    Establishment Types

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