510(k) K261488

OBSIDIO Conformable Embolic by Boston Scientific Corporation — Product Code KRD

K261488 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "OBSIDIO Conformable Embolic". The FDA issued a decision of Substantially Equivalent on Jul 24, 2026. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Boston Scientific Corporation has 238 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 24, 2026
Date Received
May 6, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
Submission Type
510(k)

Source: FDA 510(k) database entry for K261488. Report a data issue: hello@regdatalab.com.