WIRION Embolic Protection System— 510(k) K210282

Substantially Equivalent

Cardiovascular Systems, Inc.

FDA 510(k) clearance K210282 for WIRION Embolic Protection System, Substantially Equivalent on 2021-03-03. Applicant: Cardiovascular Systems, Inc..

Clearance details

Applicant: Cardiovascular Systems, Inc.
Product code: Code NTE
Advisory panel: Cardiovascular
Date received: 2021-02-01
Decision date: 2021-03-03
Decision: Substantially Equivalent
Clearance type: Special
Location: St.Paul, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NTE

product code NTE

Death: 28
Injury: 1,348
Malfunction: 771
Total: 2,147

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.