DTY · Class II · 21 CFR 870.4410

FDA Product Code DTY: Sensor, Blood-gas, In-line, Cardiopulmonary Bypass

Leading manufacturers include International Biophysics Corp., Medtronic, Inc. and Cardio Metrics, Inc..

8
Total
8
Cleared
124d
Avg days
1982
Since

FDA 510(k) Cleared Sensor, Blood-gas, In-line, Cardiopulmonary Bypass Devices (Product Code DTY)

8 devices
1–8 of 8
Cleared Feb 17, 2010
BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
K093650
Medtronic, Inc.
Cardiovascular · 84d
Cleared Mar 20, 1997
CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
K963698
International Biophysics Corp.
Cardiovascular · 185d
Cleared Jan 16, 1996
BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
K954501
Medtronic Bio-Medicus, Inc.
Cardiovascular · 110d
Cleared Nov 05, 1990
CDI (TM) SYSTEM 100 MONITORING SYSTEM
K902654
3M Health Care, Ltd.
Cardiovascular · 143d
Cleared Aug 14, 1990
PERFUSION MONITOR
K900860
Cardio Metrics, Inc.
Cardiovascular · 172d

About Product Code DTY - Regulatory Context