Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1828132

FEI Number

1828132

Entity Name

BOSTON SCIENTIFIC CORPORATION

City/State/Country

SPENCER, IN, US

Establishment Address

780 BROOKSIDE DRIVE, SPENCER, IN 47460, US

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

K071066

PMA Number

N/A

All Registered Proprietary Names

Pneumatic Inflator Trapezoid RX Wireguided Retrieval Basket Urovac Bladder Evacuator Connector Ureteral Catheter Connector Connector Drainage Bag Connector Connecting Tube EMBLEM S-ICD Subcutaneous Electrode EMBLEM S-ICD Electrode EMBLEM S-ICD Programmer EMBLEM S-ICD Pulse Generator EMBLEM MRI S-ICD Subcutaneous Implantable Cardioverter Defibrillator EMBLEM S-ICD Electrode Delivery System EMBLEM S-ICD Electrode Insertion System EMBLEM S-ICD Subcutaneous Implantable Cardioverter Defibrillator EMBLEM S-ICD System Patient Screen Tool Log Data Card for the Model 3200 EMBLEM S-ICD Programmer Power Supply for S-ICD Programmer Tool Wand for SICD Programmer 3200 SQ-RX Pulse Generator AdVance XP Male Sling System 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 Endovive Securi-T Percutaneous Replacement Gastrostomy Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2016-05-12
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2016-05-12
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2002-09-12
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2019-11-06
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2015-11-25
LQC	Lithotriptor, Biliary Mechanical	Gastroenterology, Urology	Class 2	876.4500	2016-12-05
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-01-14
PWJ	Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	Obstetrics/Gynecology	Class 2	884.4910	2021-12-16
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2008-01-03
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2014-05-29
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-01-20
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2023-01-20
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	1992-07-22
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-09-09
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2011-12-12
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male	General, Plastic Surgery	Class 2	878.3300	2022-03-10
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2025-05-01
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2008-01-03
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2014-01-07
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2014-01-07
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2015-11-25
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2021-05-04
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	1992-07-22
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-11-27
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2012-12-11
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	1992-07-22
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2017-03-29
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2008-12-11
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2018-05-31
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-01-14
EYK	Connector, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	1992-07-22
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2026-01-06
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2026-01-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-10-15
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2012-03-09
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2012-03-09
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2018-01-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-10
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-01-11
BTG	Brush, Biopsy, Bronchoscope (Non-Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-01-14
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2010-09-15
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	1992-07-22
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2010-09-15
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2012-10-07
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2012-10-07
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-01-03
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2007-05-10
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male	General, Plastic Surgery	Class 2	878.3300	2017-03-17
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2025-08-28
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2008-01-03
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-03-26
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2008-01-03
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2008-01-03
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2008-01-03
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-11-14
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2017-11-14
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2005-08-01
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2003-04-24
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	1983-09-09
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2023-07-15
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	1999-03-08
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2016-07-21
PAH	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling	General, Plastic Surgery	Class 2	878.3300	2008-12-11
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-12-02
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-06-24
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2018-05-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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

Registration Number	Establishment Name	Location
3025434462	Obsidio Inc	Maple Grove, MN, US
3005619880	Boston Scientific Corporation	Roswell, GA, US
3015425075	NALU MEDICAL	Carlsbad, CA, US
3015289131	FARAPULSE, INC.	Menlo Park, CA, US
3022298579	Boston Scientific Cardiac Diagnostic Technologies, Inc.	Arden Hills, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04

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

Similar Registrations

Registration Number	Establishment Name	Location
3020707080	FUJIFILM medwork GmbH	Hochstadt/Aisch Bavaria, DE
2183446	DIVERSATEK HEALTHCARE INC	Milwaukee, WI, US
3003790304	GYRUS ACMI, INC.	Westborough, MA, US
3010288205	Hangzhou AGS MedTech Co., Ltd.	Hangzhou Zhejiang, CN
1651395	Medivators Inc	Conroe, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1828132. Last updated year: 2026. Please use registration number 1828132 when referencing this establishment in official correspondence.