Boston Scientific Medical Device (Malaysia) SDN BHD

FDA Device Registration & Listing · Taman Perindustrian Batu Kawan Pulau Pinang, MY · Registration 3014222368

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014222368
FEI Number
3014222368
Entity Name
Boston Scientific Medical Device (Malaysia) SDN BHD
City/State/Country
Taman Perindustrian Batu Kawan Pulau Pinang, MY
Establishment Address
PMT 741, Persiaran Cassia Selatan 1, Bandar Cassia, Taman Perindustrian Batu Kawan Pulau Pinang 14110, MY
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
N
Expiration Date (Year)
2026
510(k) Number
K152231
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2022-03-29
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2020-06-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-05-11
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-12-22
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2014-09-05
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-08-21
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2014-09-05
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2015-10-06
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2016-12-20
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2014-03-10
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-02-16

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

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
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31
K992169 Advanced Cardiovascular Systems, Inc. ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE 1999-10-28
K012534 Advanced Cardiovascular Systems, Inc. HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING 2002-01-24

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 3014222368. Last updated year: 2026. Please use registration number 3014222368 when referencing this establishment in official correspondence.
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