Medical Device Manufacturer · US , Marlborough , MA

Boston Scientific Corporation

228 submissions · 215 cleared · Since 2005
228
Total
215
Cleared
1
Denied

Boston Scientific Corporation — FDA 510(k) Submissions

Boston Scientific Corporation has submitted 228 FDA 510(k) premarket notifications since 2005, of which 215 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stents, Drains And Dilators For The Biliary Ducts, Computer, Diagnostic, Programmable, Catheter, Percutaneous, Catheter, Angioplasty, Peripheral, Transluminal, Wire, Guide, Catheter . Use the specialty filter in the sidebar to narrow results.

228 devices
1–25 of 228
TheraSphere 360? Y-90 Management Platform
K260479 · LLZ System, Image Processing,... · Radiology
Mar 2026 28d
SpaceOAR Vue System (SV-2101)
K260119 · OVB Hydrogel Spacer · Radiology
Feb 2026 27d
Moses? 200 D/F/L Laser Fiber (M0068130100); Moses? 365 D/F/L Laser Fiber (M0068130110); Moses? 550 D/F/L Laser Fiber (M0068130120)
K252529 · GEX Powered Laser Surgical... · General & Plastic Surgery
Oct 2025 80d
OBSIDIO? Conformable Embolic (M0013972101010)
K253376 · KRD Device, Vascular, For... · Cardiovascular
Oct 2025 30d
TheraSphere 360? Y-90 Management Platform
K252547 · LLZ System, Image Processing,... · Radiology
Oct 2025 77d
Radial Jaw 4 Pulmonary Biopsy Forceps
K252921 · BWH Forceps, Biopsy,... · Anesthesiology
Sep 2025 14d
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)
K252703 · FGB Ureteroscope And... · Gastroenterology & Urology
Sep 2025 28d
LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
K252593 · MXD Recorder, Event,... · Cardiovascular
Sep 2025 28d
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
K251759 · GEX Powered Laser Surgical... · Gastroenterology & Urology
Jul 2025 30d
VIKING? Fixed Curve Diagnostic Catheter
K250310 · DRF Catheter, Electrode... · Cardiovascular
Jun 2025 144d
Rezum System
K250584 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
Jun 2025 104d
OptiMap? System
K251344 · DQK Computer, Diagnostic,... · Cardiovascular
May 2025 28d
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
K250824 · FAD Stent, Ureteral · Gastroenterology & Urology
Apr 2025 28d
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
K250517 · FED Endoscopic Access... · Gastroenterology & Urology
Mar 2025 28d
Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
K250066 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Feb 2025 27d
AdVance? XP Male Sling System (720163-03)
K242960 · OTM Mesh, Surgical, For... · Gastroenterology & Urology
Nov 2024 51d
EP?XT? Unidirectional Steerable Diagnostic Catheter; Dynamic Tip? Unidirectional Steerable Diagnostic Catheter; Dynamic XT? Unidirectional Steerable Diagnostic Catheter
K240366 · DRF Catheter, Electrode... · Cardiovascular
Nov 2024 269d
RHYTHMIA HDx? Mapping System
K241227 · DQK Computer, Diagnostic,... · Cardiovascular
Aug 2024 119d
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
K241683 · LIT Catheter, Angioplasty,... · Cardiovascular
Jul 2024 29d
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)
K241598 · FGB Ureteroscope And... · Gastroenterology & Urology
Jul 2024 27d
Agile Esophageal Stent System
K233837 · ESW Prosthesis, Esophageal · Gastroenterology & Urology
Apr 2024 122d
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
K234046 · MQR Stent, Colonic, Metallic,... · Gastroenterology & Urology
Mar 2024 78d
WATCHMAN TruSteer Access System (M635TU90050)
K240018 · DQY Catheter, Percutaneous · Cardiovascular
Feb 2024 30d
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
K233645 · FGB Ureteroscope And... · Gastroenterology & Urology
Dec 2023 28d
FARADRIVE? Steerable Sheath
K233248 · DRA Catheter, Steerable · Cardiovascular
Dec 2023 74d

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