KRL · Class II · 21 CFR 870.4205

FDA Product Code KRL: Detector, Bubble, Cardiopulmonary Bypass

Leading manufacturers include Cobe Laboratories, Inc., Sorin Biomedica, Fiat, USA, Inc. and 3M Health Care, Sarns.

14
Total
14
Cleared
93d
Avg days
1980
Since

FDA 510(k) Cleared Detector, Bubble, Cardiopulmonary Bypass Devices (Product Code KRL)

14 devices
1–14 of 14
Cleared Jan 18, 2011
STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
K103469
Sorin Group Deutschland GmbH
Cardiovascular · 55d
Cleared Jun 08, 2009
CAPIOX BUBBLE TRAP WITH X-COATING
K090698
Terumo Cardiovascular Systems
Cardiovascular · 83d
Cleared May 17, 2007
EDAC QUANTIFIER
K071231
Luna Innovations, Inc.
Cardiovascular · 14d
Cleared Oct 31, 1996
AUTOMATIC TUBING CLAMP SYSTEM (ATC)
K961364
Rocky Mountain Research, Inc.
Cardiovascular · 205d
Cleared Oct 29, 1996
ELS AUTOMATIC TUBING CLAMP SYSTEM
K961598
Rocky Mountain Research, Inc.
Cardiovascular · 203d
Cleared May 24, 1994
SARNS ULTRASONIC AIR SENSOR
K940651
3M Health Care, Sarns
Cardiovascular · 98d
Cleared Feb 04, 1994
SARNS AIR DETECTION SYSTEM
K935977
3M Health Care, Sarns
Cardiovascular · 53d
Cleared May 18, 1993
STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE
K925661
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 189d
Cleared Feb 02, 1993
STOCKERT 1/4 BUBBLE SENSOR
K925541
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 91d
Cleared Jul 09, 1991
CAPIOX(R) BUBBLE TRAP
K911632
Terumo Medical Corp.
Cardiovascular · 89d
Cleared Feb 03, 1987
CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
K864619
Shiley, Inc.
Cardiovascular · 71d
Cleared Jul 18, 1986
COBE ACCESSORY INTERFACE MODULE (AIM)
K861860
Cobe Laboratories, Inc.
Cardiovascular · 65d
Cleared Aug 02, 1984
COBE AEPS
K842054
Cobe Laboratories, Inc.
Cardiovascular · 72d
Cleared Dec 22, 1980
ARTERIAL BUBBLE TRAP K-20
K803102
Delta Medical Industries
Cardiovascular · 13d

About Product Code KRL - Regulatory Context