WIRION— 510(k) K180023

Substantially Equivalent

Gardia Medical , Ltd.

FDA 510(k) clearance K180023 for WIRION, Substantially Equivalent on 2018-03-21. Applicant: Gardia Medical , Ltd..

Clearance details

Applicant: Gardia Medical , Ltd.
Product code: Code NTE
Advisory panel: Cardiovascular
Date received: 2018-01-03
Decision date: 2018-03-21
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.