DTX · Class II · 21 CFR 870.4300

FDA Product Code DTX: Gas Control Unit, Cardiopulmonary Bypass

Leading manufacturers include Spectrum Medical , Ltd..

10
Total
10
Cleared
74d
Avg days
1979
Since

FDA 510(k) Cleared Gas Control Unit, Cardiopulmonary Bypass Devices (Product Code DTX)

10 devices
1–10 of 10
Cleared May 04, 2021
Quantum Mini Ventilation Module
K210669
Spectrum Medical , Ltd.
Cardiovascular · 60d

About Product Code DTX - Regulatory Context

DTX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →