Boston Scientific Corporation - FDA 510(k) Cleared Devices
Recent clearances: LithoVue Elite Digital Flexible Ureteroscope System, Navigator™ Flex Ureteral Access Sheath Set, OBSIDIO Conformable Embolic
238
Total
225
Cleared
1
Denied
FDA 510(k) Regulatory Record - Boston Scientific Corporation Cardiovascular ✕
103 devices
Cleared
Jul 24, 2026
OBSIDIO Conformable Embolic
Cardiovascular
79d
Cleared
Jul 24, 2026
FARADRIVE™ Steerable Sheath (M004PF21M402)
Cardiovascular
28d
Cleared
May 15, 2026
TruSelect™ 2.6 Microcatheter
Cardiovascular
67d
Cleared
Oct 30, 2025
OBSIDIO™ Conformable Embolic (M0013972101010)
Cardiovascular
30d
Cleared
Sep 12, 2025
LUX-Dx II Insertable Cardiac Monitor (M302)
Cardiovascular
28d
Cleared
Jun 27, 2025
VIKING™ Fixed Curve Diagnostic Catheter
Cardiovascular
144d
Cleared
May 28, 2025
OptiMap™ System
Cardiovascular
28d
Cleared
Nov 01, 2024
EP•XT™ Unidirectional Steerable Diagnostic Catheter
Cardiovascular
269d
Cleared
Aug 29, 2024
RHYTHMIA HDx™ Mapping System
Cardiovascular
119d
Cleared
Jul 10, 2024
Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 )
Cardiovascular
29d
Cleared
Feb 01, 2024
WATCHMAN TruSteer Access System (M635TU90050)
Cardiovascular
30d
Cleared
Dec 11, 2023
FARADRIVE™ Steerable Sheath
Cardiovascular
74d
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