Class Class II

Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) (K250821)

K250821 2025-12-12 Traditional
Home/ Devices/ Horizon AF Plus System…

Description

Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) by Eurosets Srl, an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250821
Clearance Date2025-12-12
Clearance TypeTraditional
Product CodeDTZ
Regulation Number870.4350

Categories

Need More Information?

Contact the manufacturer or request a quote for this device.

Request Quote
Scroll to Top