Medical Device Manufacturer · US , San Jose , CA

Boston Scientific - FDA 510(k) Cleared Devices

57 submissions · 51 cleared · Since 2001

57

Total

51

Cleared

1

Denied

FDA 510(k) cleared devices by Boston Scientific Cardiovascular ✕

25 devices

1-12 of 25

Cleared Mar 20, 2025

iSLEEVE Introducer Set

Cardiovascular · 30d

Cleared Oct 03, 2024

OBSIDIO™ Conformable Embolic

Cardiovascular · 42d

Cleared May 25, 2023

Stingray LP Catheter

Cardiovascular · 30d

Cleared Apr 25, 2023

Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable

Cardiovascular · 60d

Cleared Apr 20, 2022

EKOS+ Endovascular Device

Cardiovascular · 26d

Cleared Mar 24, 2022

Emerge Monorail PTCA Dilatation Catheter

Cardiovascular · 20d

Cleared Nov 19, 2021

EkoSonic Endovascular Device

Cardiovascular · 221d

Cleared May 29, 2020

iLab Polaris Multi-Modality Guidance System

Cardiovascular · 28d

Cleared Mar 07, 2019

iSLEEVE Introducer Set

Cardiovascular · 34d

Cleared Jul 20, 2018

WATCHMAN TruSeal Access System

Cardiovascular · 109d

Cleared Apr 12, 2018

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire

Cardiovascular · 16d

Cleared Jul 24, 2015

Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters

Cardiovascular · 260d