510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KRJClass II

Filter, Prebypass, Cardiopulmonary Bypass

21 CFR 870.4280 / Cardiovascular
FDA source (opens on fda.gov)

KRJ is the FDA product code for Filter, Prebypass, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4280. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KRJ
Device name
Filter, Prebypass, Cardiopulmonary Bypass
Regulation
21 CFR 870.4280
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
24
Ingested recalls
0

Clearances, product code KRJ

By decision year
24 clearances under product code KRJ with a decision year between 1978 and 1999, 1981 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KRJ by decision year
YearClearances
19781
19791
19802
19814
19832
19842
19851
19861
19871
19884
19891
19901
19941
19992

Applicants with the most clearances

Product code KRJ
Applicants holding the most 510(k) clearances under product code KRJ
ApplicantClearances
Medtronic Blood Systems, Inc.4
Medical, Inc.3
Pall Biomedical Products Co.3
American Omni Medical, Inc.2
Bentley Laboratories, Inc.2
Delta Medical Industries2
Pentair Filtration Solutions2
Avecor Cardiovascular, Inc.1
Gelman Sciences, Inc.1
Gish Biomedical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code