Boston Scientific Corporation - FDA 510(k) Cleared Devices
228
Total
215
Cleared
1
Denied
100 devices
Cleared
Nov 09, 2017
WATCHDOG Hemostasis Valve Kit
Cardiovascular
87d
Cleared
Nov 03, 2017
Fixed Patient Leads ECG Cable (Model 3153)
Cardiovascular
66d
Cleared
Aug 21, 2017
MAMBA and MAMBA FLEX Microcatheters
Cardiovascular
96d
Cleared
Jul 25, 2017
Rubicon 14, 18 and 35 Support Catheters
Cardiovascular
29d
Cleared
Jul 06, 2017
PSA Cable
Cardiovascular
111d
Cleared
Jun 30, 2017
ACUITY Pro Lead Delivery System
Cardiovascular
29d
Cleared
May 16, 2017
Direxion and Direxion HI-FLO Torqueable Microcatheters
Cardiovascular
138d
Cleared
Mar 24, 2017
FFR Link, FFR Signal Processing Module
Cardiovascular
60d
Cleared
Mar 23, 2017
Guidezilla II Guide Extension Catheter
Cardiovascular
120d
Cleared
Mar 22, 2017
Fathom-16 Steerable Guidewires
Cardiovascular
20d
Cleared
Mar 10, 2017
RHYTHMIA HDx Mapping System
Cardiovascular
157d
Cleared
Dec 14, 2016
Emerge PTCA Dilatation Catheter
Cardiovascular
30d
Cleared
Dec 14, 2016
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail...
Cardiovascular
29d
Cleared
Nov 04, 2016
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation...
Cardiovascular
73d
Cleared
Jun 23, 2016
NC Quantum Apex PTCA Dilatation Catheter
Cardiovascular
90d
Cleared
Jun 22, 2016
OptiCross 18, 30 MHz Peripheral Imaging Catheter
Cardiovascular
119d
Cleared
May 19, 2016
OptiCross X, 40 MHz Coronary Imaging Catheter
Cardiovascular
28d
Cleared
Feb 26, 2016
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz...
Cardiovascular
30d
Cleared
Feb 25, 2016
OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6,...
Cardiovascular
69d
Cleared
Feb 12, 2016
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
Cardiovascular
189d
Cleared
Dec 16, 2015
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire,...
Cardiovascular
163d
Cleared
Dec 04, 2015
Stingray LP Catheter
Cardiovascular
101d
Cleared
Oct 29, 2015
Impulse Angiographic Catheter, Expo Angiographic Catheter
Cardiovascular
48d
Cleared
Oct 21, 2015
CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels,...
Cardiovascular
30d
Cleared
Oct 06, 2015
Comet Pressure Guidewire
Cardiovascular
113d
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