EMBOTRAP III Revascularization Device— 510(k) K193063

Substantially Equivalent

Neuravi, Ltd.

FDA 510(k) clearance K193063 for EMBOTRAP III Revascularization Device, Substantially Equivalent on 2020-07-14. Applicant: Neuravi, Ltd..

Clearance details

Applicant: Neuravi, Ltd.
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2019-11-04
Decision date: 2020-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

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.