Medical Device Manufacturer · US , Marlborough , MA

Boston Scientific Corporation - FDA 510(k) Cleared Devices

236 submissions · 223 cleared · Since 2005

Recent clearances: OBSIDIO Conformable Embolic, FARADRIVE™ Steerable Sheath (M004PF21M402), TheraSphere 360™ Y-90 Management Platform

Official Website

236

Total

223

Cleared

1

Denied

FDA 510(k) Regulatory Record - Boston Scientific Corporation Radiology ✕

6 devices

1-6 of 6

Cleared Jul 24, 2026

TheraSphere 360™ Y-90 Management Platform

Radiology · 7d

Cleared Mar 13, 2026

TheraSphere 360™ Y-90 Management Platform

Radiology · 28d

Cleared Feb 10, 2026

SpaceOAR Vue System (SV-2101)

Radiology · 27d

Cleared Oct 28, 2025

TheraSphere 360™ Y-90 Management Platform

Radiology · 77d

Cleared Aug 28, 2020

SpaceOAR System

Radiology · 21d

Cleared Dec 19, 2017

LumiCoil Platinum Fiducial Marker

Radiology · 70d