BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Boston Scientific Corporation

    Reg #: 3010705768 · FEI: 3010705768 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    54
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    Boston Scientific Corporation
    Registration Number
    3010705768
    FEI Number
    3010705768
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    309 Waverley Oaks Rd.
    City
    Waltham
    State
    MA
    ZIP
    02452
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192438
    PMA Number
    P020025

    Owner / Operator

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

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
    Cardiac Ablation Percutaneous Catheter LPB
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Cable, Electrode IKD

    Proprietary Names

    INTELLAGEN Remote Control Connection Cable 30 Meter Cable IntellaTip MiFi XP Sterile Cable IntellaTip MiFi Reference Cable Non-Sterile Electrophysiology Cable IntellaTip MiFi Filter Module RF Frequency Filter IntellaTip MiFi XP Temperature Ablation Catheter Blazer Prime XP Temperature Ablation Catheter IntellaNav MiFi XP Temperature Ablation Catheter Electrophysiology Cable Non-Sterile Cable Blazer Solid-Tip Ablation Cather Cable, Sterile Cable Maestro 4000 RF Cardiac Ablation Controller Maestro 4000 RF Cardiac Ablation Pod 100 Maestro Foot Switch IntellaNav XP Temperature Ablation Catheter Maestro 4000 Remote Control Cable, IntellaNav Ablation Catheter Rhythmia Mapping System IntellaNav CB - Maestro Rhythmia HDx Ablation Connection Box Blazer II XP Temperature Ablation Catheter INTELLAGEN Serial Communication Cable 5 Meter INTELLAGEN Serial Communication Cable 15 Meter INTELLAGEN Grounding Cable 3 Meter Non-Sterile Cable INTELLAGEN RF Generator Kit INTELLAGEN Remote Control Connection Cable 10 Meter INTELLAGEN Remote Control Connection Cable 25 Meter INTELLAGEN Foot Pedal Extension Cable 7 Meter INTELLAGEN Foot Pedal INTELLAGEN Remote Control Kit INTELLAGEN ECG Connection Cable 3 Meter INTELLAGEN Serial Communication Cable 3 Meter INTELLAGEN Catheter Adapter Cable 0.3 Meter INTELLAGEN Remote Control Connection Cable 15 Meter Rhythmia HDx Ablation Connection Box - for INTELLAGEN Cable, Maestro 4000 Blazer Open-Irrigated Ablation Catheter MetriQ Irrigation Tubing Set Open-Irrigation Tubing Set MetriQ Foot Switch MetriQ Pump Irrigation Pump IntellaNav Open-Irrigated Ablation Catheter IntellaTip MiFi Open-Irrigated Ablation Catheter IntellaNav MiFi Open-Irrigated Ablation Catheter Rhythmia HDx Ablation Connection Box Maestro RHYTHMIA HDx Ablation Connection Box – IntellaNav StablePoint INTELLAGEN Irrigation Pump Connection Cable 3 Meter INTELLAGEN Irrigation Pump Connection Cable 10 Meter IntellaNav StablePoint Catheter Cable Rhythmia HDx Ablation Connection Box - IntellaNav StablePoint - for INTELLAGEN INTELLAGEN Irrigation Pump Kit INTELLAGEN Tubing Set Cable IntellaTip MiFi OI to Maestro 4000 IntellaNav StablePoint Ablation Catheter Cable, IntellaTip MiFi OI INTELLAGEN Irrigation Pump Connection Cable 1 Meter INTELLAGEN Irrigation Pump Connection Cable 5 Meter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility