NeVa PV Thrombectomy Device— 510(k) K201085

Substantially Equivalent

Vesalio

FDA 510(k) clearance K201085 for NeVa PV Thrombectomy Device, Substantially Equivalent on 2021-01-15. Applicant: Vesalio.

Clearance details

Applicant: Vesalio
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2020-04-23
Decision date: 2021-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashville, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

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.