Product code MSF— Gastroenterology, Urology
ALTRA FLUX 200 HEMODIALYZER
- Classification name
- Hemodialyzer, Re-Use, High Flux
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code MSF
FDA has cleared devices under product code MSF between 1998 and 2003, filed by 5 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
- 2003
- 2000
- 1998
Top applicants under product code MSF
Recent clearances under product code MSF
- K023615 — GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
- K994390 — GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
- K970679 — ALTRA FLUX 200 HEMODIALYZER
- K970681 — ALTRA NOVA 200 HEMODIALYZER
- K970653 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
- K970662 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)
- K970663 — CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)
- K970648 — PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
Data sourced from openFDA. This site is unofficial and independent of the FDA.