BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Boston Scientific Corp., Marina Bay Cust. Fulfillment Center

    Reg #: 1225687 · FEI: 3001451463 · Expires 2026
    View on FDA
    Products
    49
    Proprietary Names
    64
    Establishment Types
    3
    Classifications
    49

    Registration Details

    Registration Name
    Boston Scientific Corp., Marina Bay Cust. Fulfillment Center
    Registration Number
    1225687
    FEI Number
    3001451463
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    500 Commander Shea Boulevard
    City
    QUINCY
    State
    MA
    ZIP
    02171
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102725
    PMA Number
    P180011

    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
    Wire, Guide, Catheter DQX
    Catheter, Percutaneous DQY
    Prosthesis, Esophageal ESW
    Stent, Superficial Femoral Artery, Drug-Eluting NIU
    Catheter, Nephrostomy LJE
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Hydrogel Spacer OVB
    Device, Vascular, For Promoting Embolization KRD
    Mesh, Surgical, For Stress Urinary Incontinence, Male OTM
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Biopsy Needle FCG
    Transducer, Ultrasonic, Diagnostic ITX
    Catheter, Ultrasound, Intravascular OBJ
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Permanent Defibrillator Electrodes NVY
    Stent, Ureteral FAD
    Tube, Drainage, Suprapubic FFA
    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter OOB
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
    Device, Neurovascular Embolization HCG
    Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia NOY
    Lithotriptor, Electro-Hydraulic FFK
    Catheter, Septostomy DXF
    Introducer, Catheter DYB
    Snare, Flexible FDI
    Probe, Radiofrequency Lesion GXI
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU
    Aspiration Thrombectomy Catheter QEZ
    Catheter, Continuous Flush KRA
    Coronary Drug-Eluting Stent NIQ
    System, Appendage Closure, Left Atrial NGV
    Catheter, Coronary, Atherectomy MCX
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Stent, Iliac NIO
    Stent, Superficial Femoral Artery NIP
    Camera, Surgical And Accessories KQM
    Led Light Source NTN
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Catheter, Peripheral, Atherectomy MCW
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Stent, Coronary MAF
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Dilator, Urethral KOE
    Dilator, Catheter, Ureteral EZN
    Endoscopic Cholangiogram Kit NWT

    Proprietary Names

    ELUVIA Drug-Eluting Vascular Stent System ENDOTAK RELIANCE G Connector Tools Lead Repair Kit Lead Pulling Tip RELIANCE 4-FRONT Defibrillation Lead Suture Sleeve Accessory Lead Stylets Lead Adapter Lead Cap Kit ENDOTAK RELIANCE ENDOTAK RELIANCE SG ENDOTAK RELIANCE S AGENT Paclitaxel-Coated Balloon Catheter Ranger Paclitaxel-Coated PTA Balloon Catheter Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System 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 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 Epic Vascular Self-Expanding Stent System Innova Vascular Self-Expanding Stent System Gateway PTA Dilatation Catheter Emerge Push PTCA Dilatation Catheter Emerge PTCA Dilatation Catheter NC Emerge PTCA Dilatation Catheter REBEL Platinum Chromium Coronary Stent System

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Device in the United States for Export Only