DTW · Class II · 21 CFR 870.4340

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

Leading manufacturers include 3M Health Care, Sarns, Gambro, Inc. and Medtronic, Inc..

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 22, 1990
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)
K900910
Cobe Laboratories, Inc.
Cardiovascular · 84d
Cleared May 09, 1990
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
K900815
3M Company
Cardiovascular · 77d
Cleared Sep 30, 1987
MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE
K873206
Respiratory Support Products, Inc.
Cardiovascular · 47d
Cleared May 30, 1986
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200
K860076
Gambro, Inc.
Cardiovascular · 142d
Cleared Dec 27, 1984
STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR
K843802
Shiley, Inc.
Cardiovascular · 91d
Cleared Jul 26, 1983
UNIVERSAL LEVEL SENSOR
K831879
3M Health Care, Sarns
Cardiovascular · 43d
Cleared Oct 18, 1982
GAMBRO BLOOD LEVEL DETECTOR LCS 10
K822821
Gambro, Inc.
Cardiovascular · 28d
Cleared Jul 27, 1978
MONITOR KITS, BLOOD LEVEL
K781145
3M Health Care, Sarns
Cardiovascular · 17d

About Product Code DTW - Regulatory Context