OBSIDIO Conformable Embolic (M0013972101010)— 510(k) K253376

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K253376 for OBSIDIO Conformable Embolic (M0013972101010), Substantially Equivalent on 2025-10-30. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code KRD
Advisory panel: Cardiovascular
Date received: 2025-09-30
Decision date: 2025-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

Adverse 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, 2020-01-01 through 2026-04-23. 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.