Boston Scientific, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Boston Scientific, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Savion DLVR Guidewire, Savion FLX Guidewire
1
Total
1
Cleared
0
Denied
Boston Scientific, Inc. is a global medical device manufacturer with a manufacturing facility in Maple Grove, Hennepin, US. The company develops and markets medical devices across multiple therapeutic areas, with a strong focus on Cardiovascular solutions.
The company has received 1 FDA 510(k) clearance from 1 total submission. Boston Scientific's regulatory activity in the Cardiovascular category spans from 2018 to 2018. The company is currently inactive in the FDA 510(k) clearance process, with no submissions recorded in the past five years.
Historical FDA 510(k) cleared devices include guidewire technologies designed for interventional cardiology procedures. These products reflect the company's expertise in vascular access and navigation solutions for complex cardiovascular interventions.
Explore the complete regulatory record, including device names, product codes, and clearance dates in the database.
FDA 510(k) Regulatory Record - Boston Scientific, Inc.
1 devices