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 Respiratory Support Products, 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 Jul 02, 2004
STOCKERTIR PURGE CONTROL (APC) SYSTEM
K041558
Stockert Instrumente GmbH
Cardiovascular · 22d
Cleared Nov 10, 1999
LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
K992857
Rocky Mountain Research, Inc.
Cardiovascular · 77d
Cleared Feb 22, 1996
STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER
K955152
Stoeckert Instrumente
Cardiovascular · 101d
Cleared Feb 18, 1993
STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR
K924354
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 190d
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 Oct 21, 1985
SENSOR TAPE CAT. NO. ST-45
K852407
American Omni Medical, Inc.
Cardiovascular · 137d
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