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

Hemodialyzer, Re-Use, Low Flux

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

MSE is the FDA product code for Hemodialyzer, Re-Use, Low Flux, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
MSE
Device name
Hemodialyzer, Re-Use, Low Flux
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
7
Ingested recalls
2

Clearances, product code MSE

By decision year
7 clearances under product code MSE with a decision year between 1997 and 2000, 1997 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MSE by decision year
YearClearances
19973
19982
19991
20001

Applicants with the most clearances

Product code MSE
Applicants holding the most 510(k) clearances under product code MSE
ApplicantClearances
Baxter Healthcare Corporation3
Asahi Kasei Medical MT Corp. Oita Works2
Fresenius Medical Care Renal Therapies Group, LLC1
Fresenius USA, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code