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    FDA Registration Active 🇨🇷 Costa Rica

    Boston Scientific Corporation

    Reg #: 3007695959 · FEI: 3007695959 · Expires 2026
    View on FDA
    Products
    57
    Proprietary Names
    84
    Establishment Types
    1
    Classifications
    57

    Registration Details

    Registration Name
    Boston Scientific Corporation
    Registration Number
    3007695959
    FEI Number
    3007695959
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2546 First Street, Propark
    City
    El Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K220962
    PMA Number
    P140008

    Owner / Operator

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

    US Agent

    Business Name
    BOSTON SCIENTIFIC CORPORATION
    Contact Name
    Aaron Dunbar
    Address
    300 BOSTON SCIENTIFIC WAY
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US
    Email
    [email protected]
    Phone
    651 3961414

    Products

    Device Name Product Code
    Holder, Needle, Gastroenterologic FHQ
    Catheter, Peripheral, Atherectomy MCW
    Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures PUM
    Transducer, Ultrasonic, Diagnostic ITX
    Catheter, Ultrasound, Intravascular OBJ
    Snare, Non-Electrical FGX
    Snare, Flexible FDI
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Dislodger, Stone, Biliary LQR
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Forceps, Biopsy, Non-Electric FCL
    Ligator, Esophageal MND
    Echocardiograph DXK
    Hemostatic Metal Clip For The Gi Tract PKL
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Probe, Radiofrequency Lesion GXI
    Wire, Guide, Catheter DQX
    Implant, Intragastric For Morbid Obesity LTI
    Cardiac Ablation Percutaneous Catheter LPB
    Catheter, Continuous Flush KRA
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Mechanical Thrombolysis Catheter QEY
    Generator, Lesion, Radiofrequency GXD
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Stent, Ureteral FAD
    Bronchoscope (Flexible Or Rigid) EOQ
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Catheter, Coronary, Atherectomy MCX
    Endoscopic Tissue Approximation Device OCW
    Adaptor, Catheter GCE
    Stylet For Catheter, Gastro-Urology EZB
    Laparoscope, General & Plastic Surgery GCJ
    Forceps, Biopsy, Bronchoscope (Non-Rigid) BWH
    Tube, Drainage, Suprapubic FFA
    Catheter, Cholangiography GBZ
    Forceps, Biopsy, Electric KGE
    Catheter, Nephrostomy LJE
    Introducer, Catheter DYB
    Connector, Ureteral Catheter EYK
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
    Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula ODD
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Ligator, Hemorrhoidal FHN
    Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection NFA
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss QTD
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Instrument, Manual, Surgical, General Use MDM
    Percutaneous Atrial Catheter Kit OFK
    Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse PWI
    Bronchoscope Accessory KTI
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Accessories, Catheter KGZ
    Temporary Carotid Catheter For Embolic Capture NTE

    Proprietary Names

    Ureteral Stent Positioners ORBERA Intragastric Balloon Electrophysiology Cable Sterile Cable Maestro 4000 Controller, RF Cardiac Ablation Controller Blazer Prime HTD Temperature Ablation Catheter Maestro 4000 Remote Control Maestro 4000 Pod, 100W, RF Cardiac Ablation Pod, 100W Maestro Foot Switch IntellaNav ST Ablation Catheter Blazer II HTD Temperature Ablation Catheter Cable, IntellaNav Ablation Catheter Blazer II Temperature Ablation Catheter INTELLAGEN Foot Pedal INTELLAGEN Remote Control Connection Cable 10 Meter INTELLAGEN Remote Control Connection Cable 25 Meter INTELLAGEN Grounding Cable 3 Meter Blazer Solid-Tip Ablation Catheter Cable, Sterile Cable INTELLAGEN Serial Communication Cable 15 Meter INTELLAGEN Remote Control Connection Cable 30 Meter Maestro Remote Control Cable Non-Sterile Cable (Controller to Pump or Remote Control) INTELLAGEN Serial Communication Cable 3 Meter Rhythmia HDx Ablation Connection Box - for INTELLAGEN INTELLAGEN Remote Control Kit INTELLAGEN Catheter Adapter Cable 0.3 Meter INTELLAGEN Remote Control Connection Cable 15 Meter INTELLAGEN Serial Communication Cable 5 Meter INTELLAGEN RF Generator Kit INTELLAGEN Foot Pedal Extension Cable 7 Meter INTELLAGEN ECG Connection Cable 3 Meter RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device Rotaglide Lubricant Rotablator Dynaglide Foot Pedal wireClip Torquer ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device ROTAPRO Advancer Burr Advancing Device ROTAPRO Rotational Atherectomy System Console Kit ROTAWIRE Drive and wireClip Torquer Floppy RotaWire and wireClip Torquer Extra Support RotaLink Advancer Catheter Advancing Device RotaWire and wireClip Torquer Floppy Rotablator Rotational Atherectomy System Console Kit RotaLink Burr Exchangeable Burr Catheter ROTAWIRE Drive and wireClip Torquer Extra Support Connector Ureteral Catheter Connector Connector Drainage Bag Connector Connecting Tube 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 IntellaNav XP Temperature Ablation Catheter Rhythmia Mapping System IntellaNav CB - Maestro Rhythmia HDx Ablation Connection Box Blazer II XP Temperature Ablation Catheter Non-Sterile Cable Flexima Nephrostomy Catheter System Kit Flexima Nephrostomy Catheter System TLA Introducer Needle and Sheath Set Percutaneous Access Needle Percuflex Locking Loop with Fader Tip Nephrostomy Catheter Kit Malecot Nephrostomy Catheter Set Flexima Nephrostomy Catheter System Kit with Dissolving Tip Flexima Nephrostomy Catheter System with Dissolving Tip JINRO Pigtail Nephrostomy Catheter Kit Percuflex Locking Loop Nephrostomy Catheter with Fader Tip Re-entry Malecot Nephrostomy Catheter Set Percuflex Locking Loop All Purpose Drainage Catheter with Fader Tip Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Percutaneous Access Needle with Echogenic Tip JINRO Pigtail Nephrostomy Catheter Placement Kit JINRO Pigtail Nephrostomy Catheter Percuflex Locking Loop Nephrostomy Catheter VTC Nephrostomy Catheters System Kit VTC Nephrostomy Catheters System Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Kit Percutaneous Access Set NaviGuide Percutaneous Access Needle

    Establishment Types

    Manufacture Medical Device