Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle— 510(k) K183615

Substantially Equivalent

Avenu Medical, Inc.

FDA 510(k) clearance K183615 for Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle, Substantially Equivalent on 2019-01-25. Applicant: Avenu Medical, Inc..

Clearance details

Applicant: Avenu Medical, Inc.
Product code: Code PQK
Advisory panel: Cardiovascular
Date received: 2018-12-26
Decision date: 2019-01-25
Decision: Substantially Equivalent
Clearance type: Special
Location: San Juan Capistrano, CA, US

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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.