KRI · Class I · 21 CFR 870.4200

FDA Product Code KRI: Accessory Equipment, Cardiopulmonary Bypass

Leading manufacturers include Shiley, Inc., C.R. Bard, Inc. and Travenol Laboratories, S.A..

42
Total
42
Cleared
66d
Avg days
1977
Since

FDA 510(k) Cleared Accessory Equipment, Cardiopulmonary Bypass Devices (Product Code KRI)

42 devices
1–24 of 42
Cleared Feb 19, 1987
STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP
K864890
Shiley, Inc.
Cardiovascular · 66d
Cleared Jul 17, 1986
STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1
K862510
Shiley, Inc.
Cardiovascular · 16d
Cleared Sep 29, 1983
SHILEY GAS FILTER
K832704
Shiley, Inc.
Cardiovascular · 49d
Cleared Mar 02, 1982
TMO INTEGRATED CIRCUIT SYSTEM
K820406
Travenol Laboratories, S.A.
Cardiovascular · 18d
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

About Product Code KRI - Regulatory Context