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

Dialyzer, Single Coil

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

FHS is the FDA product code for Dialyzer, Single Coil, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FHS
Device name
Dialyzer, Single Coil
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
12
Ingested recalls
0

Clearances, product code FHS

By decision year
12 clearances under product code FHS with a decision year between 1976 and 1981, 1977 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FHS by decision year
YearClearances
19762
19773
19781
19791
19803
19812

Applicants with the most clearances

Product code FHS
Applicants holding the most 510(k) clearances under product code FHS
ApplicantClearances
Erika, Inc.6
Gambro, Inc.2
Travenol Laboratories, S.A.2
Bellco Artifidial Organ Spec., Inc.1
Bentley Laboratories, 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 FHS.