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

Set, Dialysis, Single Needle With Uni-Directional Pump

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

FIF is the FDA product code for Set, Dialysis, Single Needle With Uni-Directional Pump, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FIF
Device name
Set, Dialysis, Single Needle With Uni-Directional Pump
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
6
Ingested recalls
0

Clearances, product code FIF

By decision year
6 clearances under product code FIF with a decision year between 1977 and 1987, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FIF by decision year
YearClearances
19771
19791
19802
19821
19871

Applicants with the most clearances

Product code FIF
Applicants holding the most 510(k) clearances under product code FIF
ApplicantClearances
Cardio Med Supplies, Inc.1
Cd Medical, Inc.1
Cobe Laboratories, Inc.1
Extracorporeal Medical Specialities, Inc.1
Medical Components, Inc.1
Sorensen Research1

Companies listing this code with FDA

Companies whose registered establishments list this code

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