OBSIDIO Conformable Embolic— 510(k) K261488
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K261488 for OBSIDIO Conformable Embolic, Substantially Equivalent on 2026-07-24. Applicant: Boston Scientific Corporation. Device class: 2.
Summary
Boston Scientific's OBSIDIO Conformable Embolic is filed under KRD, vascular devices for promoting embolization. The record doesn't give its composition or how it's supplied.
Class II, 21 CFR 870.3300. Cardiovascular is both the classification panel and the review panel, and it was a Traditional 510(k).
Boston Scientific filed from Maple Grove, Minnesota. Review took 79 calendar days (May 6 to July 24, 2026).
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Product code KRD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code KRD
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code KRD
product code KRD- Death
- 119
- Injury
- 1,869
- Malfunction
- 7,015
- Other
- 1
- Total
- 9,004
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.