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
76-100 of 229
Cleared Dec 18, 2020
Advanix Biliary Stent with NaviFlex RX Delivery System
K203162 · FGE
Gastroenterology & Urology · 56d
Cleared Dec 03, 2020
ORISE ProKnife
K200404 · KNS
Gastroenterology & Urology · 288d
Cleared Oct 08, 2020
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy...
K202478 · FDI
Gastroenterology & Urology · 41d
Cleared Oct 06, 2020
iSleeve Introducer Set
K202584 · DYB
Cardiovascular · 28d
Cleared Oct 02, 2020
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
K202218 · QEW
Cardiovascular · 57d
Cleared Sep 15, 2020
Athletis PTA Balloon Dilatation Catheter
K201170 · LIT
Cardiovascular · 137d
Cleared Sep 01, 2020
Resolution 360™ ULTRA Clip
K193424 · PKL
Gastroenterology & Urology · 266d
Cleared Aug 28, 2020
SpaceOAR System
K202224 · OVB
Radiology · 21d
Cleared Aug 17, 2020
WallFlex Colonic Stent System with Anchor Lock Delivery System
K201159 · MQR
Gastroenterology & Urology · 109d
Cleared Jul 28, 2020
TRUSELECT Microcatheter
K201792 · KRA
Cardiovascular · 28d
Cleared Jul 23, 2020
AVVIGO Guidance System
K201713 · DQK
Cardiovascular · 30d
Cleared Jun 26, 2020
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx...
K193473 · MXD
Cardiovascular · 193d
Cleared May 21, 2020
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
K200483 · FBN
General & Plastic Surgery · 84d
Cleared Apr 17, 2020
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex...
K200257 · MQR
Gastroenterology & Urology · 74d
Cleared Apr 17, 2020
Opticross 35 15 MHz Peripheral Imaging Catheter
K200733 · ITX
Cardiovascular · 28d
Cleared Feb 19, 2020
Sentinel Cerebral Protection System
K192460 · PUM
Cardiovascular · 163d
Cleared Jan 16, 2020
Resectr Tissue Resection Device
K191538 · HIH
Obstetrics & Gynecology · 220d
Cleared Jan 02, 2020
Ureteral Stent Systems, Biliary Drainage Catheters
K191446 · FAD
Gastroenterology & Urology · 216d
Cleared Dec 23, 2019
Comet II Pressure Guidewire
K193279 · DXO
Cardiovascular · 26d
Cleared Dec 13, 2019
EXALT Model D Single-Use Duodenoscope, EXALT Controller
K193202 · FDT
Gastroenterology & Urology · 23d
Cleared Nov 27, 2019
Rhythmia HDxTM Mapping System
K192438 · DQK
Cardiovascular · 82d
Cleared Oct 25, 2019
IntellaMap Orion High Resolution Mapping Catheter
K192360 · DRF
Cardiovascular · 56d
Cleared Aug 26, 2019
AXIOS Stent and Electrocautery Enhanced Delivery System
K192043 · PCU
Gastroenterology & Urology · 26d
Cleared Aug 16, 2019
Tria Soft Ureteral Stent
K191609 · FAD
Gastroenterology & Urology · 60d
Cleared Aug 07, 2019
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
K191871 · DYB
Cardiovascular · 26d

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