| 2026-09-14 |
K261438 |
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) |
DTZ |
Class II |
Cardiovascular |
| 2025-12-12 |
K250821 |
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) |
DTZ |
Class II |
Cardiovascular |
| 2025-11-24 |
K242503 |
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) |
DTZ |
Class II |
Cardiovascular |
| 2021-12-10 |
K202510 |
AMG PMP Infant |
DTZ |
Class II |
Cardiovascular |
| 2021-04-01 |
K202206 |
AMG PMP Pediatric |
DTZ |
Class II |
Cardiovascular |