510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FILClass II

System, Dialysate Delivery, Single Pass

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

FIL is the FDA product code for System, Dialysate Delivery, Single Pass, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FIL
Device name
System, Dialysate Delivery, Single Pass
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
8
Ingested recalls
0

Clearances, product code FIL

By decision year
8 clearances under product code FIL with a decision year between 1977 and 2002, 1977 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FIL by decision year
YearClearances
19773
19781
19791
19891
19901
20021

Applicants with the most clearances

Product code FIL
Applicants holding the most 510(k) clearances under product code FIL
ApplicantClearances
Travenol Laboratories, S.A.2
Baxter Healthcare Corporation1
Cyberex Corp.1
Extracorporeal Medical Specialities, Inc.1
Fresenius USA, Inc.1
Gambro, Inc.1
Hemametrics1

Companies listing this code with FDA

Companies whose registered establishments list this code