Zipline Access Catheter— 510(k) K240711

Substantially Equivalent

Perfuze, Ltd.

FDA 510(k) clearance K240711 for Zipline Access Catheter, Substantially Equivalent on 2024-10-17. Applicant: Perfuze, Ltd..

Clearance details

Applicant: Perfuze, Ltd.
Product code: Code QJP
Advisory panel: Cardiovascular
Date received: 2024-03-15
Decision date: 2024-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code QJP

product code QJP

Death: 43
Injury: 233
Malfunction: 1,010
Total: 1,286

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.