RayFlow— 510(k) K222023

Substantially Equivalent

Hexacath

FDA 510(k) clearance K222023 for RayFlow, Substantially Equivalent on 2023-04-06. Applicant: Hexacath.

Clearance details

Applicant: Hexacath
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2022-07-11
Decision date: 2023-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rueil Malmaison, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.