Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2134265

FEI Number

3002095335

Entity Name

BOSTON SCIENTIFIC CORPORATION

City/State/Country

Maple Grove, MN, US

Establishment Address

Two Scimed Place, Maple Grove, MN 55311, 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

K231176

PMA Number

N/A

All Registered Proprietary Names

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 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 AGENT Paclitaxel-Coated Balloon Catheter Express SD Renal/Biliary Premounted Stent System ELUVIA Drug-Eluting Vascular Stent System Innova Vascular Self-Expanding Stent System Guidezilla II PV Guide Extension Catheter REBEL 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 Ranger Paclitaxel-Coated PTA Balloon Catheter TheraSphereY-90 Glass Microspheres

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MCX	Catheter, Coronary, Atherectomy	Unknown	Class 3	N/A	2008-01-22
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-09-20
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2015-10-05
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2014-09-19
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2017-10-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-10-15
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2021-10-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-10-15
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2021-10-15
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2011-04-25
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2014-10-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-04-04
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2014-10-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2005-08-01
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2016-07-27
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2024-02-28
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-03-27
OOB	Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter	Unknown	Class 3	N/A	2024-03-12
NIN	Stent, Renal	Unknown	Class 3	N/A	2008-12-23
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-01-11
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-10-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-01-26
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2017-01-26
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2017-01-26
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2017-01-26
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2019-10-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-10-11
NIU	Stent, Superficial Femoral Artery, Drug-Eluting	Unknown	Class 3	N/A	2018-09-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-10-08
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2024-10-08
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2011-01-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-07-18
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-07-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-07-18
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2023-07-18
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2022-04-26
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2022-04-26
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-08-02
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2015-08-05
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2014-10-29
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2014-10-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-10-15
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-05-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-10-21
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2015-10-21
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2015-10-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-10-21
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2012-09-24
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2010-03-25
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-03-25
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-08-03
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2020-08-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-03-18
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2024-09-16
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-09-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-01-11
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2019-10-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-03-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-11-01
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2019-10-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-01-10
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2019-10-11
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-01-09
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2014-10-29
MAF	Stent, Coronary	Unknown	Class 3	N/A	2014-07-22
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-10-10
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-12-10
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2024-11-25
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2016-12-20
NGV	System, Appendage Closure, Left Atrial	Unknown	Class 3	N/A	2015-03-17
NTE	Temporary Carotid Catheter For Embolic Capture	Cardiovascular	Class 2	870.1250	2024-10-14
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2024-11-19
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-09-09
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2014-10-29
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2014-10-29
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2017-01-26
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2016-01-27
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2016-01-27
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-05-01
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2019-07-09
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2019-07-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-07-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-07-09
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-10-11
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2019-10-11
NIO	Stent, Iliac	Unknown	Class 3	N/A	2012-12-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-04-24
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2014-08-06
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2023-08-29
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-08-29
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-02-05
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-10-11
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2019-10-11
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2024-06-03
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2020-03-30
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2024-09-16
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2019-10-11
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2013-07-18
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2014-10-29
DXK	Echocardiograph	Cardiovascular	Class 2	870.2330	2016-04-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-04-14
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-10-10
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	2018-06-12
DXK	Echocardiograph	Cardiovascular	Class 2	870.2330	2018-06-12
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-09-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-09-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-09-27
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2023-09-27
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2024-10-09
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-12-13
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2014-10-29
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2015-10-13
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2015-10-13
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2014-02-18
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2020-11-02
PUM	Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures	Cardiovascular	Class 2	870.1251	2020-03-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-09-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2006-09-14
NAW	Microspheres Radionuclide	Unknown	Class 3	N/A	2021-03-25
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2013-10-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-10
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2013-04-11
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2022-03-29
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-06-28

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 →

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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
Z-0014-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
Z-0015-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
Z-0016-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
Z-0017-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
Z-0018-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
Z-0019-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
Z-0020-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter
Z-0021-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
Z-0022-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
Z-0023-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
Z-0024-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2134265. Last updated year: 2026. Please use registration number 2134265 when referencing this establishment in official correspondence.