Boston Scientific Corporation - FDA 510(k) Cleared Devices
228
Total
215
Cleared
1
Denied
100 devices
Cleared
Oct 06, 2015
iLab Polaris Multi-Modality Guidance System
Cardiovascular
113d
Cleared
Sep 21, 2015
ZelanteDVT Thrombectomy Set
Cardiovascular
126d
Cleared
Apr 22, 2015
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels,...
Cardiovascular
79d
Cleared
Jan 15, 2015
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire,...
Cardiovascular
28d
Cleared
Oct 08, 2014
IDC INTERLOCKING DETACHABLE COIL
Cardiovascular
134d
Cleared
Aug 21, 2014
MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
Cardiovascular
73d
Cleared
Aug 07, 2014
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION...
Cardiovascular
86d
Cleared
Jul 21, 2014
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE...
Cardiovascular
202d
Cleared
Jul 03, 2014
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
Cardiovascular
113d
Cleared
Apr 28, 2014
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
Cardiovascular
35d
Cleared
Jun 05, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM
Cardiovascular
111d
Cleared
Oct 26, 2012
TORQUE DEVICE
Cardiovascular
28d
Cleared
Mar 22, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER...
Cardiovascular
142d
Cleared
Jan 17, 2012
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
Cardiovascular
90d
Cleared
Jan 11, 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
Cardiovascular
30d
Cleared
Oct 18, 2011
V-14 CONTROL WIRE GUIDEWIRE
Cardiovascular
27d
Cleared
Jun 30, 2011
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
Cardiovascular
30d
Cleared
May 31, 2011
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
Cardiovascular
21d
Cleared
Sep 04, 2009
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
Cardiovascular
25d
Cleared
Sep 20, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
Cardiovascular
19d
Cleared
Apr 12, 2006
SYMMETRY BALLOON DILATATION CATHETER
Cardiovascular
5d
Cleared
Apr 12, 2006
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER
Cardiovascular
5d
Cleared
Mar 15, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
Cardiovascular
9d
Cleared
Jan 31, 2006
FIBERED IDC OCCLUSION SYSTEM
Cardiovascular
21d
Cleared
Aug 16, 2005
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM
Cardiovascular
19d
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