510(k) clearance
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
- 510(k) number
- K261438
- Applicant
- Eurosets S.R.L
- Decision date
- Sep 14, 2026
- Date received
- Apr 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DTZ
- Device type
- Oxygenator, Cardiopulmonary Bypass
- Device class
- Class II
- Regulation
- 21 CFR 870.4350
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Medolla, IT