DTX · Class II · 21 CFR 870.4300

FDA Product Code DTX: Gas Control Unit, Cardiopulmonary Bypass

Leading manufacturers include Spectrum Medical , Ltd. and Cordis Corp..

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
Cleared Oct 16, 2020
Quantum Ventilation Module
K202733
Spectrum Medical , Ltd.
Cardiovascular · 28d
Cleared Oct 18, 2018
Quantum Ventilation Module
K181942
Spectrum Medical , Ltd.
Cardiovascular · 90d
Cleared Dec 05, 1979
STANICOR, OMNI-STAN,MOD 333B,334A GAMMA
K792348
Cordis Corp.
Cardiovascular · 16d

About Product Code DTX - Regulatory Context