Medical Device Manufacturer · US , Marlborough , MA

Boston Scientific Corporation - FDA 510(k) Cleared Devices

229 submissions · 216 cleared · Since 2005
229
Total
216
Cleared
1
Denied
229 devices
176-200 of 229
Cleared Oct 16, 2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
K141584 · JCT
General & Plastic Surgery · 125d
Cleared Oct 08, 2014
IDC INTERLOCKING DETACHABLE COIL
K141378 · KRD
Cardiovascular · 134d
Cleared Aug 22, 2014
MUSTANG BALLOON DIALATION CATHETER
K141597 · FGE
Gastroenterology & Urology · 70d
Cleared Aug 21, 2014
MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
K141521 · LIT
Cardiovascular · 73d
Cleared Aug 07, 2014
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION...
K141236 · LOX
Cardiovascular · 86d
Cleared Jul 21, 2014
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE...
K134031 · LOX
Cardiovascular · 202d
Cleared Jul 03, 2014
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
K140641 · DYB
Cardiovascular · 113d
Cleared Jul 02, 2014
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
K133110 · FGE
Gastroenterology & Urology · 275d
Cleared May 14, 2014
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY...
K133700 · FGE
Gastroenterology & Urology · 162d
Cleared Apr 28, 2014
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · MTD
Cardiovascular · 35d
Cleared Apr 02, 2014
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K133933 · KNS
Gastroenterology & Urology · 100d
Cleared Jan 24, 2014
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
K133987 · FDI
Gastroenterology & Urology · 29d
Cleared Jan 08, 2014
OCCLUDER OCCLUSION BALLOON CATHETER
K133750 · EYB
Gastroenterology & Urology · 30d
Cleared Jan 03, 2014
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K133312 · ODG
Gastroenterology & Urology · 67d
Cleared Dec 06, 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K130004 · ESW
Gastroenterology & Urology · 338d
Cleared Jun 05, 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM
K130382 · DXC
Cardiovascular · 111d
Cleared May 22, 2013
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · EZN
Gastroenterology & Urology · 58d
Cleared Apr 11, 2013
SHORT PORT BLUNT TIP TROCAR
K130121 · GCJ
General & Plastic Surgery · 84d
Cleared Dec 13, 2012
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT...
K122459 · OTP
Obstetrics & Gynecology · 122d
Cleared Dec 03, 2012
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611,...
K122660 · PKL
Gastroenterology & Urology · 94d
Cleared Oct 26, 2012
TORQUE DEVICE
K123024 · DQX
Cardiovascular · 28d
Cleared Sep 28, 2012
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY...
K122072 · FGE
Gastroenterology & Urology · 74d
Cleared May 02, 2012
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K120983 · ESW
Gastroenterology & Urology · 30d
Cleared Mar 22, 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER...
K113220 · LOX
Cardiovascular · 142d
Cleared Mar 15, 2012
LEVEEN SUPERSLIM NEEDLE ELECTRODE
K113090 · GEI
General & Plastic Surgery · 148d

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