HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)— 510(k) K261438

Name: FDA 510(k) clearance K261438
Creator: U.S. Food and Drug Administration
Published: 2026-09-14

Substantially Equivalent

Eurosets S.R.L

FDA 510(k) clearance K261438 for HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305), Substantially Equivalent on 2026-09-14. Applicant: Eurosets S.R.L. Device class: 2.

Summary

HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) is from Eurosets S.R.L, filed under product code DTZ (Oxygenator, Cardiopulmonary Bypass). The record doesn't describe the device beyond its name and code.

Class II, 21 CFR 870.4350. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.

Eurosets filed from Medolla, Italy. The decision came 137 calendar days after FDA received it (April 30 to September 14, 2026).

Clearance details

Applicant: Eurosets S.R.L
Product code: Product code DTZ
Device class: Class 2
Regulation: 21 CFR 870.4350
Advisory panel: Cardiovascular
Date received: 2026-04-30
Decision date: 2026-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medolla, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTZ

view all

More clearances from Eurosets S.R.L

view all

Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

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.