KRL · Class II · 21 CFR 870.4205

FDA Product Code KRL: Detector, Bubble, Cardiopulmonary Bypass

Leading manufacturers include Cobe Laboratories, Inc., 3M Health Care, Sarns and Delta Medical Industries.

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 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 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