FDA 510(k) Applications Submitted by BOSTON SCIENTIFIC CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K183177 11/16/2018 Nitinol Thermocouple (TCN) Electrode Boston Scientific Corporation
K141236 05/13/2014 NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corporation
K212228 07/16/2021 WATCHMAN FXD Curve Access System Boston Scientific Corporation
DEN230019 03/27/2023 AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) Boston Scientific Corporation
K223469 11/17/2022 WallFlexÖ Biliary RX Stent System Boston Scientific Corporation
K213422 10/20/2021 EkoSonic Endovascular Device, EKOS+ Endovascular Device Boston Scientific Corporation
K230551 02/28/2023 Visual-ICE Cryoablation System 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
K182315 08/27/2018 Magic Torque DLVR Guidewire Boston Scientific Corporation
K182275 08/22/2018 Seal Single Use Biopsy Valve Boston Scientific Corporation
K060959 04/07/2006 SYMMETRY BALLOON DILATATION CATHETER Boston Scientific Corporation
K151313 05/18/2015 ZelanteDVT Thrombectomy Set BOSTON SCIENTIFIC CORPORATION
K211847 06/15/2021 AdVance XP Male Sling System Boston Scientific Corporation
K201792 06/30/2020 TRUSELECT Microcatheter Boston Scientific Corporation
K203132 10/19/2020 AXIOS Stent and Electrocautery Enhanced Delivery System 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
K191538 06/10/2019 Resectr Tissue Resection Device Boston Scientific Corporation
K152842 09/29/2015 WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL BOSTON SCIENTIFIC CORPORATION
K211030 04/06/2021 EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor Boston Scientific Corporation
K231533 05/26/2023 Habib EndoHPB Boston Scientific Corporation
K181439 06/01/2018 SpyGlass DS and DS II Direct Visualization System Boston Scientific Corporation
K222014 07/08/2022 EXALT Model B Single-Use Bronchoscope Boston Scientific Corporation
K142922 10/08/2014 SpyGlass DS Direct Visualization System BOSTON SCIENTIFIC CORPORATION
K193202 11/20/2019 EXALT Model D Single-Use Duodenoscope, EXALT Controller Boston Scientific Corporation
K183636 12/26/2018 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller Boston Scientific Corporation
K230453 02/21/2023 OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter Boston Scientific Corporation
K222568 08/24/2022 OptiCrossÖ 18 Peripheral Imaging Catheter Boston Scientific Corporation
K213593 11/12/2021 OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD Boston Scientific Corporation
K230269 01/31/2023 UltraflexÖ Tracheobronchial Stent System Boston Scientific Corporation
K200257 02/03/2020 WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System Boston Scientific Corporation
K201159 04/30/2020 WallFlex Colonic Stent System with Anchor Lock Delivery 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
K223824 12/21/2022 POLARSHEATHÖ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAPÖ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAPÖ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZEÖ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZEÖ Esophageal Temperature S Boston Scientific Corporation
K211375 05/04/2021 BlazerÖ Dx-20 Bidirectional Steerable Diagnostic Catheter Boston Scientific Corporation
K211494 05/13/2021 Polaris X Unidirectional Steerable Diagnostic Catheter Boston Scientific Corporation
K060572 03/06/2006 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation
K203162 10/23/2020 Advanix Biliary Stent with NaviFlex RX Delivery System Boston Scientific Corporation
K193424 12/10/2019 Resolution 360Ö ULTRA Clip 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
K183085 11/06/2018 CoreDxÖ Pulmonary Mini-Forceps 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
K192460 09/09/2019 Sentinel Cerebral Protection System 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
K220962 04/01/2022 ROTAPRO Rotational Atherectomy System Boston Scientific Corporation
K200260 02/03/2020 Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System Boston Scientific Corporation
K213398 10/18/2021 EMBOLD Fibered Detachable Coil System Boston Scientific Corporation
K220112 01/13/2022 AXIOS Stent and Electrocautery-Enhanced Delivery System Boston Scientific Corporation
K182975 10/25/2018 MAKO 7 Boston Scientific Corporation
K200483 02/27/2020 SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller Boston Scientific Corporation
K221340 05/09/2022 iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) Boston Scientific Corporation
K211960 06/24/2021 Agile Esophageal OTW Stent 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
K202224 08/07/2020 SpaceOAR System Boston Scientific Corporation
K200404 02/19/2020 ORISE ProKnife 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
K201170 05/01/2020 Athletis PTA Balloon Dilatation Catheter Boston Scientific Corporation
K200733 03/20/2020 Opticross 35 15 MHz Peripheral Imaging Catheter 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
K221124 04/18/2022 MANTIS Clip Boston Scientific Corporation
K222503 08/18/2022 Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip Boston Scientific Corporation
K172520 08/21/2017 CRE RX Biliary Balloon Dilatation Catheter Boston Scientific Corporation
K191446 05/31/2019 Ureteral Stent Systems, Biliary Drainage Catheters Boston Scientific Corporation
K231549 05/30/2023 Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System Boston Scientific Corporation
K190603 03/08/2019 Tria Firm Ureteral Stent Boston Scientific Corporation
K191609 06/17/2019 Tria Soft Ureteral Stent 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
K182169 08/10/2018 AdVance XP Male Sling Boston Scientific Corporation
K180144 01/18/2018 Agile Esophageal Stent System Boston Scientific Corporation
K181905 07/16/2018 AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System Boston Scientific Corporation
K192043 07/31/2019 AXIOS Stent and Electrocautery Enhanced Delivery 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
K230051 01/06/2023 14F iSLEEVEÖ Introducer Set Boston Scientific Corporation
K223592 12/01/2022 AdvanixÖ Pancreatic Stent and NaviFlexÖ Rapid Exchange (RX) Pancreatic Delivery System and Pushers Boston Scientific Corporation
K190401 02/19/2019 MAMBA and MAMBA Flex Microcatheters Boston Scientific Corporation
K230884 03/30/2023 AVVIGO'+ Multi-Modality Guidance System Boston Scientific Corporation
K201713 06/23/2020 AVVIGO Guidance System Boston Scientific Corporation
K193279 11/27/2019 Comet II Pressure Guidewire Boston Scientific Corporation
K191871 07/12/2019 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set Boston Scientific Corporation
K202584 09/08/2020 iSleeve Introducer Set 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
K210353 02/08/2021 AutoCap RX Boston Scientific Corporation
K223616 12/05/2022 AcquireÖ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device Boston Scientific Corporation
K230706 03/14/2023 EMBOLDÖ Soft Detachable Coil System Boston Scientific Corporation
K183619 12/26/2018 Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device Boston Scientific Corporation
K191789 07/03/2019 Stonetome Stone Removal Device Boston Scientific Corporation
K212582 08/16/2021 SpyGlass Discover Balloon Dilation Catheter Boston Scientific Corporation
K203548 12/04/2020 EndoArmorÖ + Surgical Gown Boston Scientific Corporation
K232651 08/31/2023 BLAZERÖ Dx-20 Bidirectional Steerable Diagnostic 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
K192438 09/06/2019 Rhythmia HDxTM Mapping System Boston Scientific Corporation
K173251 10/10/2017 LumiCoil Platinum Fiducial Marker Boston Scientific Corporation
K203322 11/12/2020 SpyGlass Discover Retrieval Basket Boston Scientific Corporation
K211072 04/12/2021 Safety Trocar Cannula Boston Scientific Corporation
K141378 05/27/2014 IDC INTERLOCKING DETACHABLE COIL Boston Scientific Corporation
K211934 06/22/2021 APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Cath 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
K212490 08/09/2021 AVVIGO Guidance System II 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
K223633 12/05/2022 RubiconÖ Control Support Catheter (H749394323506A1) 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
K210608 03/01/2021 LUX-Dx Insertable Cardiac Monitor Boston Scientific Corporation
K170815 03/17/2017 PSA Cable Boston Scientific Corporation
K193473 12/16/2019 LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US Boston Scientific Corporation
K220796 03/18/2022 IntellaMap Orion High Resolution Mapping Catheter 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
K191008 04/16/2019 iLab Polaris Multi-Modality Guidance System 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
K192360 08/30/2019 IntellaMap Orion High Resolution Mapping Catheter 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
K211223 04/23/2021 Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System 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
K210889 03/25/2021 iLab Polaris Multi-Modality Guidance 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
K232162 07/21/2023 Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome Boston Scientific Corporation
K202478 08/28/2020 Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares Boston Scientific Corporation
K113101 10/19/2011 EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL Boston Scientific Corporation
K221515 05/25/2022 StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring 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
K202218 08/06/2020 ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device 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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact