Data / Medical devices / Malaysia / Boston Scientific Medical Device (Malaysia) SDN BHD
Boston Scientific Medical Device (Malaysia) SDN BHD: FDA-registered device maker in Taman Perindustrian Batu Kawan Pulau Pinang, Malaysia, 14 510(k) clearances
Boston Scientific Medical Device (Malaysia) SDN BHD is registered with the FDA (registration 3014222368) in Taman Perindustrian Batu Kawan Pulau Pinang, Malaysia. It lists 7 device types. The FDA files 14 510(k) clearances under its listings, the newest dated July 9, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014222368
- Address
- PMT 741, Persiaran Cassia Selatan 1 Bandar Cassia, Taman Perindustrian Batu Kawan Pulau Pinang, Malaysia, 14110
- Owner or operator
- Boston Scientific Corporation (9912058)
- Roles
- Manufacturer
- First device listed
- March 10, 2014
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | GCA | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Manufacturer | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Manufacturer | accessdata.fda.gov |
| Percutaneous Catheter, Ultrasound | PPN | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 9, 2025 | K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers | GEX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 25, 2025 | K250225 | Bolt Intravascular Lithotripsy (IVL) System | PPN | Substantially Equivalent | Bolt Medical, Inc. | accessdata.fda.gov |
| May 6, 2022 | K212582 | SpyGlass Discover Balloon Dilation Catheter | GCA | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 24, 2022 | K220629 | Emerge Monorail PTCA Dilatation Catheter | LOX | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| April 12, 2018 | K180795 | JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire | DQX | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| December 14, 2016 | K163174 | Emerge PTCA Dilatation Catheter | LOX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| February 12, 2016 | K152231 | Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire | DQX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 16, 2015 | K151840 | Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire | DQX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| August 22, 2014 | K141597 | MUSTANG BALLOON DIALATION CATHETER | FGE | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| August 21, 2014 | K141521 | MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| August 7, 2014 | K141236 | NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | LOX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| February 28, 2014 | K132810 | GLADIATOR ELITE PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| June 15, 2012 | K120870 | GREENLIGHT MOXY FIBER OPTIC | GEX | Substantially Equivalent | American Medical Systems | accessdata.fda.gov |
| December 1, 2006 | K062719 | GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES | GEX | Substantially Equivalent | Laserscope | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Percutaneous Catheter, Ultrasound
- All makers of Powered Laser Surgical Instrument
- All makers of Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Updated July 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.