Boston Scientific Corp - FDA 510(k) Cleared Devices

Boston Scientific Corp, is a global medical device manufacturer headquartered in San Jose, US. The company develops and markets devices across multiple therapeutic areas including cardiovascular, gastroenterology, and surgical specialties.

Boston Scientific has maintained a strong FDA 510(k) regulatory presence since 1988. The company has received 411 FDA 510(k) clearances from 432 total submissions. Recent clearances in 2024 demonstrate continued innovation and active market engagement across cardiovascular and gastroenterology device categories.

Recent cleared devices reflect the company's focus on interventional technologies. Products include vascular catheters, endoscopic stents, drainage systems, and guidewires. These devices serve critical roles in minimally invasive procedures across cardiology, gastroenterology, and urology specialties.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database above.

510(k) submissions have been managed by Intertek Testing Services as regulatory consultant. 4 devices have linked clinical trials registered on ClinicalTrials.gov.