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

Dialyzer, Parallel Flow

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FJG is the FDA product code for Dialyzer, Parallel Flow, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FJG
Device name
Dialyzer, Parallel Flow
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
36
Ingested recalls
0

Clearances, product code FJG

By decision year
36 clearances under product code FJG with a decision year between 1977 and 1994, 1981 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code FJG by decision year
YearClearances
19773
19784
19796
19806
19818
19821
19862
19902
19922
19942

Applicants with the most clearances

Product code FJG
Applicants holding the most 510(k) clearances under product code FJG
ApplicantClearances
Gambro, Inc.7
Cobe Laboratories, Inc.4
Extracorporeal Medical Specialities, Inc.4
Hospal Medical Corp.4
Cyberex Corp.3
Medical, Inc.3
Cobe Renal Care, Inc.2
Travenol Laboratories, S.A.2
Akcess Medical Products, Inc.1
Bellco Artifidial Organ Spec., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FJG.