KRJ · Class II · 21 CFR 870.4280

FDA Product Code KRJ: Filter, Prebypass, Cardiopulmonary Bypass

Leading manufacturers include Medical, Inc., Pall Biomedical Products Co. and Delta Medical Industries.

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 Oct 01, 1999
POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
K990276
Porous Media Corp.
Cardiovascular · 246d
Cleared Feb 01, 1999
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
K982385
Porous Media Corp.
Cardiovascular · 207d
Cleared Apr 03, 1990
PREBYPASS FILTER, CAT. NO. FPB-5
K900672
American Omni Medical, Inc.
Cardiovascular · 49d
Cleared Feb 29, 1988
ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE
K875094
Pall Biomedical Products Co.
Cardiovascular · 81d
Cleared Jun 08, 1987
PREBYPASS FILTER
K871350
American Omni Medical, Inc.
Cardiovascular · 63d
Cleared Jun 02, 1986
INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70
K861226
Medical, Inc.
Cardiovascular · 62d
Cleared Aug 03, 1984
SOLUTION CLARIFICATION UNIT
K842141
Pall Biomedical Products Co.
Cardiovascular · 65d
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 Jun 08, 1983
ULTIPORE PREBYPASS PLUS FILTER
K831286
Pall Biomedical Products Co.
Cardiovascular · 49d
Cleared Oct 13, 1981
PRE-BYPASS FILTER
K812539
Gelman Sciences, Inc.
Cardiovascular · 40d
Cleared Aug 25, 1981
INTERFACE PRE BYPASS PRIME FILTER
K812240
Medical, Inc.
Cardiovascular · 14d
Cleared Aug 25, 1981
INTERFACE PRE BYPASS PRIME FILTER #90
K812244
Medical, Inc.
Cardiovascular · 14d
Cleared Mar 05, 1981
PRE-BYPASS FILTER
K810395
Texas Medical Products, Inc.
Cardiovascular · 15d
Cleared Dec 22, 1980
PREBYPASS FILTER CAT.#K-5
K803101
Delta Medical Industries
Cardiovascular · 13d
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
Cleared Apr 05, 1978
PREBYPASS FILTER
K780485
Delta Medical Industries
Cardiovascular · 9d

About Product Code KRJ - Regulatory Context