Ellipsys Vascular Access System— 510(k) DEN170004

Unknown

Avenu Medical, Inc.

FDA 510(k) clearance DEN170004 for Ellipsys Vascular Access System, Unknown on 2018-06-22. Applicant: Avenu Medical, Inc..

Clearance details

Applicant: Avenu Medical, Inc.
Product code: Code PQK
Advisory panel: Cardiovascular
Date received: 2017-01-10
Decision date: 2018-06-22
Decision: Unknown
Clearance type: Direct
Location: San Juan Capistrano, CA, US

View on FDA.gov ↗

Adverse events under product code PQK

product code PQK

Death: 7
Injury: 191
Total: 198

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.