KRJ · Class II · 21 CFR 870.4280

FDA Product Code KRJ: Filter, Prebypass, Cardiopulmonary Bypass

Leading manufacturers include Bentley Laboratories, Inc., Gish Biomedical, Inc. and Shiley, Inc..

24
Total
24
Cleared
67d
Avg days
1978
Since

FDA 510(k) Cleared Filter, Prebypass, Cardiopulmonary Bypass Devices (Product Code KRJ)

24 devices
1–24 of 24
Cleared Apr 17, 1984
SHILEY PREBYPASS FILTER
K840450
Shiley, Inc.
Cardiovascular · 76d
Cleared Sep 20, 1983
PRE-BYPASS FILTER #EC-PBF SERIES
K832594
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared Feb 01, 1980
CARDIOPLEGIA ADMINISTRATION SYSTEM CAS
K800135
Bentley Laboratories, Inc.
Cardiovascular · 11d
Cleared Mar 28, 1979
RECIRCULATION FILTER MODEL RF-10
K790361
Bentley Laboratories, Inc.
Cardiovascular · 34d

About Product Code KRJ - Regulatory Context