Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004859241

FEI Number

3004859241

Entity Name

BOSTON SCIENTIFIC CORPORATION

City/State/Country

La Aurora Heredia, CR

Establishment Address

302 Parkway, Global Park, La Aurora Heredia --, 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

K211494

PMA Number

N/A

All Registered Proprietary Names

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 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 Mapping System IntellaNav CB - Maestro Rhythmia HDx Ablation Connection Box Maestro RHYTHMIA HDx Ablation Connection Box IntellaNav StablePoint INTELLAGEN Serial Communication Cable 5 Meter INTELLAGEN Irrigation Pump Connection Cable 3 Meter INTELLAGEN Serial Communication Cable 3 Meter INTELLAGEN Serial Communication Cable 15 Meter INTELLAGEN Catheter Adapter Cable 0.3 Meter INTELLAGEN Foot Pedal INTELLAGEN Remote Control Kit INTELLAGEN Remote Control Connection Cable 25 Meter INTELLAGEN Remote Control Connection Cable 10 Meter Cable, IntellaNav Ablation Catheter Rhythmia HDx Ablation Connection Box - for INTELLAGEN INTELLAGEN ECG Connection Cable 3 Meter INTELLAGEN Grounding Cable 3 Meter INTELLAGEN Irrigation Pump Connection Cable 10 Meter INTELLAGEN Remote Control Connection Cable 30 Meter IntellaNav StablePoint Catheter Cable Rhythmia HDx Ablation Connection Box - IntellaNav StablePoint - for INTELLAGEN INTELLAGEN RF Generator Kit INTELLAGEN Irrigation Pump Kit INTELLAGEN Tubing Set Cable IntellaTip MiFi OI to Maestro 4000 IntellaNav StablePoint Ablation Catheter INTELLAGEN Remote Control Connection Cable 15 Meter Cable, IntellaTip MiFi OI INTELLAGEN Irrigation Pump Connection Cable 1 Meter INTELLAGEN Foot Pedal Extension Cable 7 Meter INTELLAGEN Irrigation Pump Connection Cable 5 Meter 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 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 SMARTFREEZE Cryo-Cable SMARTFREEZE Catheter Extension Cable SMARTFREEZE Cryo-Console SMARTFREEZE Inter-Connection Box SMARTFREEZE Cryo-Console Foot Switch POLARx Cryoablation Balloon Catheter SMARTFREEZE Remote Control POLARx FIT Cryoablation Balloon Catheter SMARTFREEZE Diaphragm Movement Sensor FARASTAR IEC Recording System Module ECG Output Module FARASTAR Stimulation Module Male Cable FARASTAR IEC Recording System Module ECG Trunk Cable FARASTAR AAMI Recoding System Module ECG Output Module FARASTAR AAMI Snap Cable R/L FARASTAR Recording System Module FARASTAR Catheter Connection Cable FARASTAR IEC Snap Cable C Set FARAWAVE Pulsed Field Ablation Catheter FARASTAR Mapping System Module FARASTAR Stimulation Module Cable FARASTAR Stimulation Module Y-Cable Short FARASTAR Stimulation Module Y-Cable Long FARASTAR Cable Set FARAWAVE Nav Pulsed Field Ablation Catheter FARASTAR Mapping System Module BNC-Phono Cable FARASTAR EGM Cable FARASTAR Mapping System Module Back Patch Cable Male FARASTAR Gen 2 Catheter Connection Cable FARASTAR Recording System Module ECG Output to Signal Station ECG Input Cable FARASTAR to OPAL HDx FARASTAR Stimulation Module Female Cable FARASTAR Inter-Connection Box FARASTAR EGM to EP Recording System Cable (FARAPOINT) FARASTAR Mapping System Module Auxiliary Cable FARASTAR AAMI Snap Cable V Set FARASTAR Mapping System Module Back Patch Cable FARASTAR Pulsed Field Ablation Generator FARASTAR IEC Snap Cable R/L FARASTAR Mapping System Module ABL Output to Signal Station ABL Input Cable FARASTAR to OPAL HDx FARASTAR AAMI Recording System Module ECG Trunk Cable FARASTAR Recording System Module EGM Input Module FARASTAR Recording System Module Catheter Pin Cable FARAPOINT Pulsed Field Ablation Catheter FARASTAR Recording System Module EGM Output to Singal Station EGM Input Cable FARASTAR to OPAL HDx

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-10
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2005-08-01
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2013-12-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-10-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-12-22
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2013-12-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-07-18
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2017-11-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-11-14
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2013-11-20
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-01-30
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
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	1999-03-08
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-11-14
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2016-12-15
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2023-08-02
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2012-09-24
NTE	Temporary Carotid Catheter For Embolic Capture	Cardiovascular	Class 2	870.1250	2007-07-26
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	1992-07-22
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2006-03-10
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2022-04-12
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-06-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-10
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-05-11
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-01-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-12-07
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-10
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2016-02-25
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2016-02-25
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2008-01-14
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
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2014-11-10
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-02-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-06-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-07-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-04-04
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-12-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-01-10
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
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-12-13
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2024-11-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
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
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2013-12-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-12-07
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2023-06-28
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-12-13
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2008-01-14
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-09-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-01-22
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2024-03-25
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-10
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2017-05-18
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2023-05-08
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2023-05-08
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2023-08-10
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2024-01-31
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2012-12-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-08-24
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2013-12-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-01-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-09-27

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 →

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

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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 3004859241. Last updated year: 2026. Please use registration number 3004859241 when referencing this establishment in official correspondence.