Boston Scientific Corporation
FDA 510(k) medical device clearances.
Name variants for Boston Scientific Corporation
as filed with FDA- Boston Scientific Corporation
- Boston Scientific Corporation -
Top product codes for Boston Scientific Corporation
Recent clearances by Boston Scientific Corporation
1–100 of 233- K261978 — WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System
- K260428 — RIVOS EUS Access Device (M00553900)
- K260100 — MOSES Raydar
- K260771 — TruSelect 2.6 Microcatheter
- K251273 — Asurys Fluid Management System
- K260479 — TheraSphere 360 Y-90 Management Platform
- K260119 — SpaceOAR Vue System (SV-2101)
- K252529 — Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120)
- K253376 — OBSIDIO Conformable Embolic (M0013972101010)
- K252547 — TheraSphere 360 Y-90 Management Platform
- K252921 — Radial Jaw 4 Pulmonary Biopsy Forceps
- K252703 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)
- K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
- K251759 — Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
- K250310 — VIKING Fixed Curve Diagnostic Catheter
- K250584 — Rezum System
- K251344 — OptiMap System
- K250824 — Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set
- K250517 — Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006
- K250066 — Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
- K242960 — AdVance XP Male Sling System (720163-03)
- K240366 — EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter
- K241227 — RHYTHMIA HDx Mapping System
- K241683 — Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314
- K241598 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope Reverse (without pressure monitoring) (M0067941500)
- K233837 — Agile Esophageal Stent System
- K234046 — WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
- K240018 — WATCHMAN TruSteer Access System (M635TU90050)
- K233645 — StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
- K233248 — FARADRIVE Steerable Sheath
- K233503 — 14F iSLEEVE Introducer Set
- K233207 — Polaris X Unidirectional Steerable Diagnostic Catheter
- K233318 — AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)
- K232651 — BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter
- K230884 — AVVIGO'+ Multi-Modality Guidance System
- DEN230019 — AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)
- K232162 — 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
- K223633 — Rubicon Control Support Catheter (H749394323506A1)
- K230551 — Visual-ICE Cryoablation System
- K230269 — Ultraflex Tracheobronchial Stent System
- K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- K230706 — EMBOLD Soft Detachable Coil System
- K231533 — Habib EndoHPB
- K223469 — WallFlex Biliary RX Stent System
- K230453 — OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter
- K223824 — POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor
- K221340 — iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)
- K230051 — 14F iSLEEVE Introducer Set
- K221515 — 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
- K223616 — Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
- K223592 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
- K211934 — 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 Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
- K222568 — OptiCross 18 Peripheral Imaging Catheter
- K222503 — Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
- K220112 — AXIOS Stent and Electrocautery-Enhanced Delivery System
- K220962 — ROTAPRO Rotational Atherectomy System
- K221124 — MANTIS Clip
- K222014 — EXALT Model B Single-Use Bronchoscope
- K220796 — IntellaMap Orion High Resolution Mapping Catheter
- K212582 — SpyGlass Discover Balloon Dilation Catheter
- K213398 — EMBOLD Fibered Detachable Coil System
- K203548 — EndoArmor + Surgical Gown
- K213593 — OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
- K211847 — AdVance XP Male Sling System
- K213422 — EkoSonic Endovascular Device, EKOS+ Endovascular Device
- K211960 — Agile Esophageal OTW Stent System
- K212490 — AVVIGO Guidance System II
- K211494 — Polaris X Unidirectional Steerable Diagnostic Catheter
- K211375 — Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter
- K212228 — WATCHMAN FXD Curve Access System
- K211030 — EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
- K211223 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- K210889 — iLab Polaris Multi-Modality Guidance System
- K203322 — SpyGlass Discover Retrieval Basket
- K210608 — LUX-Dx Insertable Cardiac Monitor
- K210353 — AutoCap RX
- K211072 — Safety Trocar Cannula
- K200260 — Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
- K203132 — AXIOS Stent and Electrocautery Enhanced Delivery System
- K203162 — Advanix Biliary Stent with NaviFlex RX Delivery System
- K200404 — ORISE ProKnife
- K202478 — Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
- K202584 — iSleeve Introducer Set
- K202218 — ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
- K201170 — Athletis PTA Balloon Dilatation Catheter
- K193424 — Resolution 360 ULTRA Clip
- K202224 — SpaceOAR System
- K201159 — WallFlex Colonic Stent System with Anchor Lock Delivery System
- K201792 — TRUSELECT Microcatheter
- K201713 — AVVIGO Guidance System
- K193473 — LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
- K200483 — SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
- K200257 — WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
- K200733 — Opticross 35 15 MHz Peripheral Imaging Catheter
- K192460 — Sentinel Cerebral Protection System
- K191538 — Resectr Tissue Resection Device
- K191446 — Ureteral Stent Systems, Biliary Drainage Catheters
- K193279 — Comet II Pressure Guidewire
- K193202 — EXALT Model D Single-Use Duodenoscope, EXALT Controller
- K192438 — Rhythmia HDxTM Mapping System
Data sourced from openFDA. This site is unofficial and independent of the FDA.