WIRION— 510(k) K143570

Substantially Equivalent

Gardia Medical

FDA 510(k) clearance K143570 for WIRION, Substantially Equivalent on 2015-06-04. Applicant: Gardia Medical.

Clearance details

Applicant: Gardia Medical
Product code: Code NTE
Advisory panel: Cardiovascular
Date received: 2014-12-17
Decision date: 2015-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

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.