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

Hemodialyzer, Re-Use, High Flux

21 CFR 876.5860 / Gastroenterology, Urology
FDA source (opens on fda.gov)

MSF is the FDA product code for Hemodialyzer, Re-Use, High Flux, a class II device type, regulated under 21 CFR 876.5860. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MSF
Device name
Hemodialyzer, Re-Use, High Flux
Regulation
21 CFR 876.5860
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 MSF

By decision year
8 clearances under product code MSF with a decision year between 1998 and 2003, 1998 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code MSF by decision year
YearClearances
19986
20001
20031

Applicants with the most clearances

Product code MSF
Applicants holding the most 510(k) clearances under product code MSF
ApplicantClearances
Baxter Healthcare Corporation3
Althin Medical AB an Affiliate of Baxter Intl2
Gambro Healthcare1
Gambro Renal Products1
Renal Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code