BrosMed Announces FDA 510(k) Clearance and Launch for Artimes™ Balloon Dilatation Catheter in the North America and Global Market
Release time:
2014-09-17
September 17, 2014— Following the CE approval and launch Artimes™ Balloon Dilatation Catheter, BrosMed announced FDA 510(k) clearance for Artimes™ Balloon Dilatation Catheter which is now approved and ready for sale in the United States of America and the North America market for the interventional cardiovascular use.
September 17, 2014— Following the CE approval and launch Artimes™ Balloon Dilatation Catheter, BrosMed announced FDA 510(k) clearance for Artimes™ Balloon Dilatation Catheter which is now approved and ready for sale in the United States of America and the North America market for the interventional cardiovascular use. Artimes™ rapid exchange PTCA balloon catheter is intended to be used for percutaneous transluminal coronary angioplasty (PTCA) for the purpose of improving myocardial blood flow in the localized stenotic lesion of the coronary arteries.
“It is absolutely important milestone of BrosMed accomplished in 2014. The FDA 510(k) clearance and launch of Artimes™ Balloon Catheter in the United States of America proved one more time that BrosMed products excellent performance and outstanding quality. The FDA approval definitely helps us to expand ourselves from current European markets to the North America market and later penetrate global market.” said by Stephen Lee, VP of Operation & Regulatory Affairs of the company.
About BrosMed Medical
BrosMed Medical is more than just a company; we are leading the medical device design and manufacturing revolution.
BrosMed Medical develops, manufactures and markets medical devices primarily used by interventional cardiologists, radiologists and vascular surgeons in angioplasty procedures and other minimal invasive devices.
We provide solutions to our customers through innovative design, effective supply chain management, world-class manufacturing, and flexible channels of distribution and through the development or acquisition of innovative technologies.
Join with Us!
Please fill out this form and we will get in touch within 24 hours.
* Note: Please be sure to fill in the information accurately and keep the communication unblocked. We will get in touch with you as soon as possible.
More news
BrosMed Announced CE MDR Approval of New Generation Conger™ Plus Hydrophilic Guidewires
Designed for superior crossability and maneuverability in peripheral interventions, Conger Plus now offers 116 models with expanded sizes (OD 0.018'' to 0.038'') and lengths (up to 300cm).
2025-04-25
Meet BrosMed at ESC Congress 2024
BrosMed Medical is delighted to participate in the ESC Congress 2024 from August 30th to September 2nd in London, UK.
2024-08-15
BrosMed Medical Announces Scott J. Addonizio as Chief Operating Officer
2024 August 1st – BrosMed Medical is pleased to announce the appointment of Scott J. Addonizio as its Chief Operating Officer (COO), effective immediately. Mr. Scott J. Addonizio brings a wealth of experience and expertise to BrosMed, with a distinguished career spanning almost 30 years in the medical device industry. Prior to joining BrosMed, Mr. Addonizio served as SVP at Cordis and COO at MedAlliance Swiss Medical Technology.
2024-08-01
CTO&CHIP PCI – Insights from the clinical practice (Ⅱ)
July 30, 2024 @16:00-17:30 (Beijing Time) Join BrosMed Medical on Tuesday, July 30 for an enlightening discussion that unites cardiologists from Malaysia, China, India, Tunisia and Portugal, where clinical expertise harmoniously fuses with CTO&CHIP innovation. At this exclusive webinar, we’re orchestrating a confluence of valuable insights, drawing from the collective wisdom of seasoned interventional cardiologists.
2024-07-26
BrosMed Announced CE MDR Approval of New Generation PTA SC Balloon Dilatation Catheters
May 27, 2024- BrosMed announced that it receives European Medical Device Regulation (MDR) certification for the New Generation PTA SC Balloon Dilatation Catheters (Brand Name: Polux™ Pro 014, Minerva™ Pro 018 and Atropos™ Pro 035).
2024-05-27