Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007695959

FEI Number

3007695959

Entity Name

Boston Scientific Corporation

City/State/Country

El Coyol Alajuela, CR

Establishment Address

2546 First Street, Propark, El Coyol Alajuela 20904, CR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Boston Scientific Corporation (Owner Number: 9912058)

Owner / Operator Contact Address

300 Boston Scientific Way, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201808

PMA Number

N/A

All Registered 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 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 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1997-10-20
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-09-09
PUM	Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures	Cardiovascular	Class 2	870.1251	2020-03-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-10-08
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2024-10-08
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2020-10-21
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2020-10-21
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2023-08-29
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2021-06-02
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	1992-07-22
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2004-09-13
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2016-12-05
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2015-03-31
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-01-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-06-12
DXK	Echocardiograph	Cardiovascular	Class 2	870.2330	2018-06-12
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2023-01-30
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2003-06-23
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2016-08-25
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-06-29
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2020-02-05
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2014-02-05
LTI	Implant, Intragastric For Morbid Obesity	Unknown	Class 3	N/A	2023-05-03
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2016-08-25
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2008-01-14
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2018-05-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-08-16
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2022-08-16
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-10-19
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2020-10-19
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2022-04-26
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2022-04-26
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2016-08-25
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2016-08-25
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2008-01-14
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2020-01-23
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2020-01-23
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-03-06
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-03-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-03-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-03-06
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-03
MCX	Catheter, Coronary, Atherectomy	Unknown	Class 3	N/A	2008-01-22
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2022-02-03
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2022-02-03
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2023-05-03
GCE	Adaptor, Catheter	General, Plastic Surgery	Class 1	878.4200	1993-01-01
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2002-01-15
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-10-11
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2019-10-11
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-01-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-10-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-12-23
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2016-12-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2025-05-30
BWH	Forceps, Biopsy, Bronchoscope (Non-Rigid)	Ear, Nose, Throat	Class 2	874.4680	2026-02-03
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2012-08-22
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2014-02-05
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2014-02-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-03
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-03
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2025-05-08
FFA	Tube, Drainage, Suprapubic	Gastroenterology, Urology	Class 2	876.5090	2025-05-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2008-01-14
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2010-11-18
FFA	Tube, Drainage, Suprapubic	Gastroenterology, Urology	Class 2	876.5090	2008-01-03
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2008-01-03
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-03
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-03
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-03-14
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2012-09-24
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2008-01-14
EYK	Connector, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	1992-07-22
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-03-12
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2008-01-14
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2008-01-14
ODD	Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2026-01-06
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2026-01-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2019-03-13
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-11-14
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2016-12-05
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2016-05-20
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2016-05-20
NFA	Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection	Cardiovascular	Class 2	870.1250	2004-02-27
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-10-11
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2019-10-11
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-05-01
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2020-05-01
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2005-08-01
QTD	Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss	Gastroenterology, Urology	Class 2	876.5983	2023-10-16
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2023-05-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-08-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-05-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-03
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-03
FFA	Tube, Drainage, Suprapubic	Gastroenterology, Urology	Class 2	876.5090	2008-01-03
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2008-01-03
DXK	Echocardiograph	Cardiovascular	Class 2	870.2330	2016-04-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-04-14
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2022-03-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2003-04-18
OFK	Percutaneous Atrial Catheter Kit	Cardiovascular	Class 2	870.1250	2024-08-07
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2023-05-03
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2023-05-03

Official Correspondent

No official correspondent registered.

US Agent Details

Aaron Dunbar Business: BOSTON SCIENTIFIC CORPORATION Email: aaron.dunbar@bsci.com Phone: (651) 3961414

Related Public Records

Same Entity

Boston Scientific Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

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3022298579	Boston Scientific Cardiac Diagnostic Technologies, Inc.	Arden Hills, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02
K945318	Tetra Corp.	TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA	1995-05-05
K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	2023-12-13
K251211	ABBOTT MEDICAL	ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach	2025-05-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Z-0011-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Z-0012-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Z-0013-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007695959. Last updated year: 2026. Please use registration number 3007695959 when referencing this establishment in official correspondence.