MSF · Class II · 21 CFR 876.5860

FDA Product Code MSF: Hemodialyzer, Re-use, High Flux

Leading manufacturers include Baxter Healthcare Corp, Althin Medical AB an Affiliate of Baxter Intl and Gambro Renal Products.

8
Total
8
Cleared
366d
Avg days
1998
Since

FDA 510(k) Cleared Hemodialyzer, Re-use, High Flux Devices (Product Code MSF)

8 devices
1–8 of 8
Cleared May 06, 2003
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
K023615
Gambro Renal Products
Gastroenterology & Urology · 190d
Cleared Oct 26, 2000
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
K994390
Gambro Healthcare
Gastroenterology & Urology · 303d
Cleared Jul 23, 1998
ALTRA FLUX 200 HEMODIALYZER
K970679
Althin Medical AB an Affiliate of Baxter Intl
Gastroenterology & Urology · 514d
Cleared Jul 23, 1998
ALTRA NOVA 200 HEMODIALYZER
K970681
Althin Medical AB an Affiliate of Baxter Intl
Gastroenterology & Urology · 514d
Cleared Mar 11, 1998
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
K970653
Baxter Healthcare Corp
Gastroenterology & Urology · 383d
Cleared Mar 11, 1998
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)
K970662
Baxter Healthcare Corp
Gastroenterology & Urology · 383d
Cleared Jan 11, 1998
CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)
K970663
Baxter Healthcare Corp
Gastroenterology & Urology · 324d
Cleared Jan 05, 1998
PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
K970648
Renal Systems, Inc.
Gastroenterology & Urology · 319d

About Product Code MSF - Regulatory Context