Product code MSE— Gastroenterology, Urology
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
- Classification name
- Hemodialyzer, Re-Use, Low Flux
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code MSE
FDA has cleared devices under product code MSE between 1997 and 2000, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2000
- 1999
- 1998
- 1997
Top applicants under product code MSE
Recent clearances under product code MSE
- K001685 — PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
- K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
- K970700 — FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
- K974090 — 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
- K970654 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
- K970661 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
- K970650 — ASAHI AM-R SERIES DIALYZERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.