DTX — Gas Control Unit, Cardiopulmonary Bypass Class II

FDA Device Classification

Classification Details

Product Code
DTX
Device Class
Class II
Regulation Number
870.4300
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K202733spectrum medicalQuantum Ventilation ModuleOctober 16, 2020
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K101046sorin group deutschlandSTOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEMDecember 9, 2010
K023745sechrist industriesSECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-GJanuary 17, 2003
K965214coeur laboratoriesCOEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)March 28, 1997
K8639023m health care, sarnsMODIFIED SARNS MEMBRANE OXYGENATORDecember 11, 1986
K822820gambroGAS-FLOW METER GFL 10October 18, 1982
K792348cordisSTANICOR, OMNI-STAN,MOD 333B,334A GAMMADecember 5, 1979
K790546cobe laboratoriesFLOWMETER, OPTIFLO GASMay 11, 1979