Boston Scientific Corporation - FDA 510(k) Cleared Devices

Cleared Oct 30, 2025

OBSIDIO™ Conformable Embolic (M0013972101010)

K253376 · KRD

Cardiovascular · 30d

Cleared Sep 12, 2025

LUX-Dx II Insertable Cardiac Monitor (M302)

K252593 · MXD

Cardiovascular · 28d

Cleared Jun 27, 2025

VIKING™ Fixed Curve Diagnostic Catheter

K250310 · DRF

Cardiovascular · 144d

Cleared May 28, 2025

OptiMap™ System

K251344 · DQK

Cardiovascular · 28d

Cleared Nov 01, 2024

EP•XT™ Unidirectional Steerable Diagnostic Catheter

K240366 · DRF

Cardiovascular · 269d

Cleared Aug 29, 2024

RHYTHMIA HDx™ Mapping System

K241227 · DQK

Cardiovascular · 119d

Cleared Jul 10, 2024

Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 )

K241683 · LIT

Cardiovascular · 29d

Cleared Feb 01, 2024

WATCHMAN TruSteer Access System (M635TU90050)

K240018 · DQY

Cardiovascular · 30d

Cleared Dec 11, 2023

FARADRIVE™ Steerable Sheath

K233248 · DRA

Cardiovascular · 74d

Cleared Nov 30, 2023

14F iSLEEVE Introducer Set

K233503 · DYB

Cardiovascular · 30d

Cleared Oct 27, 2023

Polaris X™ Unidirectional Steerable Diagnostic Catheter

K233207 · DRF

Cardiovascular · 29d

Cleared Sep 29, 2023

BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter

K232651 · DRF

Cardiovascular · 29d