KRI · Class I · 21 CFR 870.4200

FDA Product Code KRI: Accessory Equipment, Cardiopulmonary Bypass

Leading manufacturers include American Bentley, Shiley, Inc. and Texas Medical Products, Inc..

42
Total
42
Cleared
66d
Avg days
1977
Since
42 devices
25–42 of 42
Cleared Nov 15, 1978
FILTER, EXTRACORPOREAL BLOOD HOLDER
K781861
Surgikos, Inc.
Cardiovascular · 9d
Cleared Jul 17, 1978
PVC QUICK PRIME LINES
K780984
Norton Performance Plastics Corp.
Cardiovascular · 33d
Cleared Apr 26, 1977
VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR
K770681
Scimed Life Systems, Inc.
Cardiovascular · 15d