Boston Scientific - FDA 510(k) Cleared Devices
Recent clearances: OptiCross Coronary Imaging Catheter (H749518110), Orca Air/Water and Suction Valves, Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
58
Total
52
Cleared
1
Denied
FDA 510(k) Regulatory Record - Boston Scientific Cardiovascular ✕
26 devices
Cleared
Apr 08, 2026
OptiCross Coronary Imaging Catheter (H749518110)
Cardiovascular
26d
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