Boston Scientific - FDA 510(k) Cleared Devices
57
Total
51
Cleared
1
Denied
FDA 510(k) cleared devices by Boston Scientific Cardiovascular ✕
25 devices
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
Cleared
Jul 16, 2014
STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
Cardiovascular
77d
Cleared
May 15, 2014
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
Cardiovascular
94d
Cleared
Apr 03, 2014
ACUITY PRO LEAD DELIVERY SYSTEM
Cardiovascular
198d
Cleared
Dec 16, 2013
REMOVABLE PATIENT LEADS ECG CABLE
Cardiovascular
150d
Cleared
Mar 19, 2013
GUIDEZILLA GUIDE EXTENSION CATHETER
Cardiovascular
102d
Cleared
Jan 11, 2012
GLADIATOR PTA BALLOON DILATION CATHETER
Cardiovascular
27d
Cleared
Nov 30, 2011
CHARGER PTA BALLON DILATATION CATHETER
Cardiovascular
75d
Cleared
Nov 09, 2011
RUBICON SUPPORT CATHETER
Cardiovascular
90d
Cleared
Mar 22, 2011
MUSTANG BALLOON DILATATION CATHETERS
Cardiovascular
89d
Cleared
Mar 03, 2011
INTERLOCK FIBERED IDC OCCLUSION SYSTEM
Cardiovascular
153d
Cleared
Jun 04, 2007
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH...
Cardiovascular
61d
Cleared
Oct 05, 2006
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
Cardiovascular
51d
Cleared
Jan 22, 2002
6F MACH1/34356-XXX
Cardiovascular
18d