DTW · Class II · 21 CFR 870.4340

FDA Product Code DTW: Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

Leading manufacturers include Medtronic, Inc., Shiley, Inc. and 3M Company.

17
Total
17
Cleared
123d
Avg days
1978
Since

FDA 510(k) Cleared Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass Devices (Product Code DTW)

17 devices
1–17 of 17
Cleared May 08, 2015
Level Sensor, Level Sensor Tape
K150530
Medtronic, Inc.
Cardiovascular · 67d
Cleared Feb 21, 1992
CAPIOX LEVEL ALARM
K915337
Terumo Medical Corp.
Cardiovascular · 87d
Cleared May 09, 1990
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
K900815
3M Company
Cardiovascular · 77d
Cleared Dec 27, 1984
STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR
K843802
Shiley, Inc.
Cardiovascular · 91d

About Product Code DTW - Regulatory Context