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 Jan 30, 1981
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
K810079
3M Health Care, Sarns
Cardiovascular · 17d
Cleared Jan 16, 1981
DISPOSABLE GAS LINE FILTER
K802539
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
DISPOSABLE PARALLEL Y CONNECTORS
K802541
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Jan 16, 1981
DISPOSABLE CONNECTORS
K802542
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Dec 16, 1980
WILLIAM HARVEY OXYGENATING GAS FILTER
K802906
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Oct 02, 1979
SHILEY QUICK DISCONNECT ASSEMBLY
K791829
Shiley, Inc.
Cardiovascular · 15d
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