FDA 510(k) Applications Submitted by Boston Scientific Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K141236 05/13/2014 NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corporation
K172565 08/25/2017 Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device Boston Scientific Corporation
K060959 04/07/2006 SYMMETRY BALLOON DILATATION CATHETER Boston Scientific Corporation
K151313 05/18/2015 ZelanteDVT Thrombectomy Set BOSTON SCIENTIFIC CORPORATION
K151613 06/15/2015 iLab Polaris Multi-Modality Guidance System BOSTON SCIENTIFIC CORPORATION
K080332 02/07/2008 POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 Boston Scientific Corporation
K100712 03/12/2010 RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation
K110887 03/30/2011 INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER Boston Scientific Corporation
K112198 08/01/2011 EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation
K102336 08/18/2010 RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE Boston Scientific Corporation
K113090 10/19/2011 LEVEEN SUPERSLIM NEEDLE ELECTRODE Boston Scientific Corporation
K152572 09/09/2015 AXIOS Stent and Delivery System BOSTON SCIENTIFIC CORPORATION
K153088 10/26/2015 AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System BOSTON SCIENTIFIC CORPORATION
K133933 12/23/2013 INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER Boston Scientific Corporation
K152842 09/29/2015 WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL BOSTON SCIENTIFIC CORPORATION
K181439 06/01/2018 SpyGlass DS and DS II Direct Visualization System Boston Scientific Corporation
K142922 10/08/2014 SpyGlass DS Direct Visualization System BOSTON SCIENTIFIC CORPORATION
K163399 12/05/2016 Tria Firm Ureteral Stent Boston Scientific Corporation
K133750 12/09/2013 OCCLUDER OCCLUSION BALLOON CATHETER Boston Scientific Corporation
K060078 01/10/2006 FIBERED IDC OCCLUSION SYSTEM Boston Scientific Corporation
K170204 01/23/2017 FFR Link, FFR Signal Processing Module Boston Scientific Corporation
K180530 02/28/2018 Imager II Urology Torque Catheter Boston Scientific Corporation
K172929 09/25/2017 Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath Boston Scientific Corporation
K102527 09/02/2010 IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER Boston Scientific Corporation
K100663 03/08/2010 CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 Boston Scientific Corporation
K060572 03/06/2006 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation
K151802 07/02/2015 Resolution Clip BOSTON SCIENTIFIC CORPORATION
K102764 09/24/2010 RESOLUTION II CLIP Boston Scientific Corporation
K142973 10/14/2014 Resolution Clip Boston Scientific Corporation
K133700 12/03/2013 ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS Boston Scientific Corporation
K172591 08/29/2017 Fixed Patient Leads ECG Cable (Model 3153) Boston Scientific Corporation
K160173 01/27/2016 Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) Boston Scientific Corporation
K160514 02/24/2016 OptiCross 18, 30 MHz Peripheral Imaging Catheter BOSTON SCIENTIFIC CORPORATION
K161125 04/21/2016 OptiCross X, 40 MHz Coronary Imaging Catheter Boston Scientific Corporation
K111485 05/31/2011 FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX Boston Scientific Corporation
K153617 12/18/2015 OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) BOSTON SCIENTIFIC CORPORATION
K173837 12/18/2017 RHYTHMIA HDx Mapping System (with software Version 2.0) Boston Scientific Corporation
K113651 12/12/2011 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM Boston Scientific Corporation
K151610 06/15/2015 Comet Pressure Guidewire BOSTON SCIENTIFIC CORPORATION
K160823 03/25/2016 NC Quantum Apex PTCA Dilatation Catheter BOSTON SCIENTIFIC CORPORATION
K163174 11/14/2016 Emerge PTCA Dilatation Catheter Boston Scientific Corporation
K130004 01/02/2013 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corporation
K110833 03/25/2011 CRE BALLOON DILATATION CATHETER Boston Scientific Corporation
K091816 06/18/2009 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corporation
K112994 10/07/2011 CRE DITATATION BALLON Boston Scientific Corporation
K120983 04/02/2012 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corporation
K133987 12/26/2013 CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES Boston Scientific Corporation
K153049 10/20/2015 LithoVue System BOSTON SCIENTIFIC CORPORATION
K060323 02/09/2006 ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 Boston Scientific Corporation
K092009 07/06/2009 MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290 Boston Scientific Corporation
K181042 04/19/2018 Ultra ICE Plus û PI 9 MHz Peripheral Imaging Catheter Boston Scientific Corporation
K170759 03/13/2017 CRE Pulmonary Balloon Dilatation Catheter Boston Scientific Corporation
K172520 08/21/2017 CRE RX Biliary Balloon Dilatation Catheter Boston Scientific Corporation
K163200 11/15/2016 Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete BOSTON SCIENTIFIC CORPORATION
K171913 06/26/2017 Rubicon 14, 18 and 35 Support Catheters Boston Scientific Corporation
K162350 08/23/2016 Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Boston Scientific Corporation
K162404 08/29/2016 Express SD Biliary Monorail Premounted Stent System BOSTON SCIENTIFIC CORPORATION
K163272 11/21/2016 AXIOS Stent and Electrocautery Enhanced Delivery System Boston Scientific Corporation
K170636 03/02/2017 Fathom-16 Steerable Guidewires Boston Scientific Corporation
K140641 03/12/2014 VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA Boston Scientific Corporation
K152401 08/25/2015 Stingray LP Catheter BOSTON SCIENTIFIC CORPORATION
K130804 03/25/2013 UROMAX ULTRA BALLOON DILATATION CATHETER Boston Scientific Corporation
K122072 07/16/2012 WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE Boston Scientific Corporation
K173251 10/10/2017 LumiCoil Platinum Fiducial Marker Boston Scientific Corporation
K141378 05/27/2014 IDC INTERLOCKING DETACHABLE COIL Boston Scientific Corporation
K163701 12/29/2016 Direxion and Direxion HI-FLO Torqueable Microcatheters BOSTON SCIENTIFIC CORPORATION
K171612 06/01/2017 ACUITY Pro Lead Delivery System Boston Scientific Corporation
K172453 08/14/2017 WATCHDOG Hemostasis Valve Kit Boston Scientific Corporation
K152605 09/11/2015 Impulse Angiographic Catheter, Expo Angiographic Catheter BOSTON SCIENTIFIC CORPORATION
K130121 01/17/2013 SHORT PORT BLUNT TIP TROCAR Boston Scientific Corporation
K130382 02/14/2013 HEARTSTRING III PROXIMAL SEAL SYSTEM Boston Scientific Corporation
K111295 05/10/2011 .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS Boston Scientific Corporation
K091510 05/22/2009 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 Boston Scientific Corporation
K083627 12/08/2008 WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 Boston Scientific Corporation
K150235 02/02/2015 CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels BOSTON SCIENTIFIC CORPORATION
K152693 09/21/2015 CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels BOSTON SCIENTIFIC CORPORATION
K141521 06/09/2014 MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER Boston Scientific Corporation
K141597 06/13/2014 MUSTANG BALLOON DIALATION CATHETER Boston Scientific Corporation
K170815 03/17/2017 PSA Cable Boston Scientific Corporation
K160637 03/07/2016 Rotatable Snares BOSTON SCIENTIFIC CORPORATION
K171271 05/01/2017 Polyform Synthetic Mesh Boston Scientific Corporation
K122459 08/13/2012 PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM Boston Scientific Corporation
K140733 03/24/2014 CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER Boston Scientific Corporation
K173284 10/16/2017 OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) Boston Scientific Corporation
K173820 12/18/2017 OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) Boston Scientific Corporation
K163314 11/23/2016 Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter Boston Scientific Corporation
K151840 07/06/2015 Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire Boston Scientific Corporation
K152231 08/07/2015 Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire BOSTON SCIENTIFIC CORPORATION
K143587 12/18/2014 ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire BOSTON SCIENTIFIC CORPORATION
K172060 07/07/2017 Capio SLIM Suture Capturing Device Boston Scientific Corporation
K123024 09/28/2012 TORQUE DEVICE Boston Scientific Corporation
K162793 10/04/2016 RHYTHMIA HDx Mapping System Boston Scientific Corporation
K133110 09/30/2013 EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM Boston Scientific Corporation
K052038 07/28/2005 PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM Boston Scientific Corporation
K060960 04/07/2006 BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER Boston Scientific Corporation
K062594 09/01/2006 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation
K092455 08/10/2009 MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation
K112745 09/21/2011 V-14 CONTROL WIRE GUIDEWIRE Boston Scientific Corporation
K171452 05/17/2017 MAMBA and MAMBA FLEX Microcatheters Boston Scientific Corporation
K113101 10/19/2011 EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL Boston Scientific Corporation
K171454 05/17/2017 Interject Injection Therapy Needle Catheter Boston Scientific Corporation
K141584 06/13/2014 ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM Boston Scientific Corporation
K171809 06/19/2017 Epic Biliary Endoscopic Stent System Boston Scientific Corporation
K122660 08/31/2012 RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 Boston Scientific Corporation
K112543 09/01/2011 WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM Boston Scientific Corporation
K180785 03/26/2018 iSLEEVE Introducer Set Boston Scientific Corporation
K113220 11/01/2011 EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corporation
K134031 12/31/2013 THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER Boston Scientific Corporation
K072476 09/04/2007 THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT Boston Scientific Corporation
K161003 04/11/2016 EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Fee BOSTON SCIENTIFIC CORPORATION
K160845 03/28/2016 Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device BOSTON SCIENTIFIC CORPORATION
K151315 05/18/2015 Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle BOSTON SCIENTIFIC CORPORATION
K151895 07/10/2015 Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle BOSTON SCIENTIFIC CORPORATION
K133312 10/28/2013 EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation
K163248 11/18/2016 Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle Boston Scientific Corporation


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