DTX · Class II · 21 CFR 870.4300

FDA Product Code DTX: Gas Control Unit, Cardiopulmonary Bypass

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

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 09, 2010
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
K101046
Sorin Group Deutschland GmbH
Cardiovascular · 239d
Cleared Jan 17, 2003
SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
K023745
Sechrist Industries, Inc.
Cardiovascular · 71d
Cleared Mar 28, 1997
COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
K965214
Coeur Laboratories, Inc.
Cardiovascular · 88d
Cleared Dec 11, 1986
MODIFIED SARNS MEMBRANE OXYGENATOR
K863902
3M Health Care, Sarns
Cardiovascular · 65d
Cleared Oct 18, 1982
GAS-FLOW METER GFL 10
K822820
Gambro, Inc.
Cardiovascular · 28d
Cleared Dec 05, 1979
STANICOR, OMNI-STAN,MOD 333B,334A GAMMA
K792348
Cordis Corp.
Cardiovascular · 16d
Cleared May 11, 1979
FLOWMETER, OPTIFLO GAS
K790546
Cobe Laboratories, Inc.
Cardiovascular · 52d

About Product Code DTX - Regulatory Context