Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)— 510(k) K181725

Substantially Equivalent

Avenu Medical, Inc.

FDA 510(k) clearance K181725 for Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005), Substantially Equivalent on 2018-10-05. Applicant: Avenu Medical, Inc..

Clearance details

Applicant: Avenu Medical, Inc.
Product code: Code PQK
Advisory panel: Cardiovascular
Date received: 2018-06-29
Decision date: 2018-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF 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.