Boston Scientific Corporation - FDA 510(k) Cleared Devices
228
Total
215
Cleared
1
Denied
100 devices
Cleared
Sep 14, 2021
Polaris X Unidirectional Steerable Diagnostic Catheter
Cardiovascular
124d
Cleared
Sep 10, 2021
Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
Cardiovascular
129d
Cleared
Aug 13, 2021
WATCHMAN FXD Curve Access System
Cardiovascular
28d
Cleared
Jun 25, 2021
iLab Polaris Multi-Modality Guidance System
Cardiovascular
92d
Cleared
May 25, 2021
LUX-Dx Insertable Cardiac Monitor
Cardiovascular
85d
Cleared
Oct 06, 2020
iSleeve Introducer Set
Cardiovascular
28d
Cleared
Oct 02, 2020
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
Cardiovascular
57d
Cleared
Sep 15, 2020
Athletis PTA Balloon Dilatation Catheter
Cardiovascular
137d
Cleared
Jul 28, 2020
TRUSELECT Microcatheter
Cardiovascular
28d
Cleared
Jul 23, 2020
AVVIGO Guidance System
Cardiovascular
30d
Cleared
Jun 26, 2020
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx...
Cardiovascular
193d
Cleared
Apr 17, 2020
Opticross 35 15 MHz Peripheral Imaging Catheter
Cardiovascular
28d
Cleared
Feb 19, 2020
Sentinel Cerebral Protection System
Cardiovascular
163d
Cleared
Dec 23, 2019
Comet II Pressure Guidewire
Cardiovascular
26d
Cleared
Nov 27, 2019
Rhythmia HDxTM Mapping System
Cardiovascular
82d
Cleared
Oct 25, 2019
IntellaMap Orion High Resolution Mapping Catheter
Cardiovascular
56d
Cleared
Aug 07, 2019
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
Cardiovascular
26d
Cleared
Jul 02, 2019
iLab Polaris Multi-Modality Guidance System
Cardiovascular
77d
Cleared
Mar 15, 2019
MAMBA and MAMBA Flex Microcatheters
Cardiovascular
24d
Cleared
Sep 26, 2018
Magic Torque DLVR Guidewire
Cardiovascular
30d
Cleared
Jul 25, 2018
RHYTHMIA HDx Mapping System (with software Version 2.0)
Cardiovascular
219d
Cleared
Jun 22, 2018
iSLEEVE Introducer Set
Cardiovascular
88d
Cleared
May 17, 2018
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
Cardiovascular
28d
Cleared
Jan 17, 2018
OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD,...
Cardiovascular
30d
Cleared
Nov 16, 2017
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU)
Cardiovascular
31d
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