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
126-150 of 229
Cleared Nov 09, 2017
WATCHDOG Hemostasis Valve Kit
K172453 · DQX
Cardiovascular · 87d
Cleared Nov 03, 2017
Capio SLIM Suture Capturing Device
K172060 · PWI
Obstetrics & Gynecology · 119d
Cleared Nov 03, 2017
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · DSA
Cardiovascular · 66d
Cleared Oct 04, 2017
CRE RX Biliary Balloon Dilatation Catheter
K172520 · FGE
Gastroenterology & Urology · 44d
Cleared Aug 21, 2017
MAMBA and MAMBA FLEX Microcatheters
K171452 · DQY
Cardiovascular · 96d
Cleared Aug 09, 2017
Epic Biliary Endoscopic Stent System
K171809 · FGE
Gastroenterology & Urology · 51d
Cleared Jul 25, 2017
Rubicon 14, 18 and 35 Support Catheters
K171913 · DQY
Cardiovascular · 29d
Cleared Jul 07, 2017
Interject Injection Therapy Needle Catheter
K171454 · FBK
Gastroenterology & Urology · 51d
Cleared Jul 06, 2017
PSA Cable
K170815 · DTC
Cardiovascular · 111d
Cleared Jun 30, 2017
ACUITY Pro Lead Delivery System
K171612 · DQY
Cardiovascular · 29d
Cleared Jun 23, 2017
CRE Pulmonary Balloon Dilatation Catheter
K170759 · KTI
Ear, Nose, Throat · 102d
Cleared Jun 22, 2017
Tria Firm Ureteral Stent
K163399 · FAD
Gastroenterology & Urology · 199d
Cleared May 16, 2017
Direxion and Direxion HI-FLO Torqueable Microcatheters
K163701 · KRA
Cardiovascular · 138d
Cleared Mar 27, 2017
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K163248 · EOQ
Ear, Nose, Throat · 129d
Cleared Mar 24, 2017
FFR Link, FFR Signal Processing Module
K170204 · DRG
Cardiovascular · 60d
Cleared Mar 23, 2017
Guidezilla II Guide Extension Catheter
K163314 · DQY
Cardiovascular · 120d
Cleared Mar 22, 2017
Fathom-16 Steerable Guidewires
K170636 · DQX
Cardiovascular · 20d
Cleared Mar 10, 2017
RHYTHMIA HDx Mapping System
K162793 · DQK
Cardiovascular · 157d
Cleared Feb 18, 2017
AXIOS Stent and Electrocautery Enhanced Delivery System
K163272 · PCU
Gastroenterology & Urology · 89d
Cleared Dec 14, 2016
Emerge PTCA Dilatation Catheter
K163174 · LOX
Cardiovascular · 30d
Cleared Dec 14, 2016
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail...
K163200 · LOX
Cardiovascular · 29d
Cleared Nov 04, 2016
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation...
K162350 · LIT
Cardiovascular · 73d
Cleared Oct 12, 2016
Express SD Biliary Monorail Premounted Stent System
K162404 · FGE
Gastroenterology & Urology · 44d
Cleared Jun 23, 2016
NC Quantum Apex PTCA Dilatation Catheter
K160823 · LOX
Cardiovascular · 90d
Cleared Jun 22, 2016
OptiCross 18, 30 MHz Peripheral Imaging Catheter
K160514 · OBJ
Cardiovascular · 119d

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