Medical Device Manufacturer · US , Marlborough , MA

Boston Scientific Corporation - FDA 510(k) Cleared Devices

228 submissions · 215 cleared · Since 2005
228
Total
215
Cleared
1
Denied
97 devices
51-75 of 97
Cleared Sep 13, 2018
Seal Single Use Biopsy Valve
K182275 · OCX
Gastroenterology & Urology · 22d
Cleared Aug 23, 2018
SpyGlass DS and DS II Direct Visualization System
K181439 · FBN
Gastroenterology & Urology · 83d
Cleared Apr 10, 2018
Imager II Urology Torque Catheter
K180530 · KOD
Gastroenterology & Urology · 41d
Cleared Jan 10, 2018
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal...
K172929 · LJE
Gastroenterology & Urology · 107d
Cleared Dec 20, 2017
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx...
K172565 · PWJ
Gastroenterology & Urology · 117d
Cleared Oct 04, 2017
CRE RX Biliary Balloon Dilatation Catheter
K172520 · FGE
Gastroenterology & Urology · 44d
Cleared Aug 09, 2017
Epic Biliary Endoscopic Stent System
K171809 · FGE
Gastroenterology & Urology · 51d
Cleared Jul 07, 2017
Interject Injection Therapy Needle Catheter
K171454 · FBK
Gastroenterology & Urology · 51d
Cleared Jun 22, 2017
Tria Firm Ureteral Stent
K163399 · FAD
Gastroenterology & Urology · 199d
Cleared Feb 18, 2017
AXIOS Stent and Electrocautery Enhanced Delivery System
K163272 · PCU
Gastroenterology & Urology · 89d
Cleared Oct 12, 2016
Express SD Biliary Monorail Premounted Stent System
K162404 · FGE
Gastroenterology & Urology · 44d
Cleared Jun 17, 2016
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit...
K161003 · PIF
Gastroenterology & Urology · 67d
Cleared May 03, 2016
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K160845 · ODG
Gastroenterology & Urology · 36d
Cleared Mar 30, 2016
Rotatable Snares
K160637 · FDI
Gastroenterology & Urology · 23d
Cleared Dec 11, 2015
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced...
K153088 · PCU
Gastroenterology & Urology · 46d
Cleared Nov 13, 2015
LithoVue System
K153049 · FGB
Gastroenterology & Urology · 24d
Cleared Oct 22, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151895 · FCG
Gastroenterology & Urology · 104d
Cleared Oct 06, 2015
AXIOS Stent and Delivery System
K152572 · PCU
Gastroenterology & Urology · 27d
Cleared Aug 06, 2015
Resolution Clip
K151802 · PKL
Gastroenterology & Urology · 35d
Cleared Jan 16, 2015
SpyGlass DS Direct Visualization System
K142922 · FBN
Gastroenterology & Urology · 100d
Cleared Dec 01, 2014
Resolution Clip
K142973 · PKL
Gastroenterology & Urology · 48d
Cleared Aug 22, 2014
MUSTANG BALLOON DIALATION CATHETER
K141597 · FGE
Gastroenterology & Urology · 70d
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 02, 2014
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K133933 · KNS
Gastroenterology & Urology · 100d

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