MSFClass IILife-sustaining
Hemodialyzer, Re-use, High Flux
Gastroenterology, Urology · 21 CFR 876.5860
MDR events1,219All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances8All time
Recent MDR events
1,219 adverse event reports on file
- HEMODIALYZER, RE-USE, HIGH FLUXAug 12, 2023InjuryFreseniusMW5135127
- *Jan 13, 2015MalfunctionAsahi Kasei Medical America Inc.4449907
- CTMar 6, 2014InjuryNipro Corporation *usd*1416980-2014-07671
- POLYFLUX 24RSep 27, 2013DeathGambro Dialysatoren Gmbh9611369-2013-00006
- CTJun 29, 2011MalfunctionNipro Corporation *usd*1423500-2011-08465
- CTJun 22, 2011MalfunctionNipro Corporation *usd*1423500-2011-08098
- CTJun 22, 2011MalfunctionNipro Corporation *usd*1423500-2011-08107
- CA-HPJun 22, 2011MalfunctionNipro Corporation *usd*1423500-2011-07999
- CA-HPJun 22, 2011MalfunctionNipro Corporation *usd*1423500-2011-08000
- CTJun 22, 2011MalfunctionNipro Corporation *usd*1423500-2011-08186
Event type breakdown
Malfunction1,164
Other29
Injury23
Death3
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Gambro Renal ProductsMay 6, 2003
K023615 · GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
- Gambro HealthcareOct 26, 2000
K994390 · GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
- Althin Medical AB an Affiliate of Baxter IntlJul 23, 1998
K970681 · ALTRA NOVA 200 HEMODIALYZER
- Althin Medical AB an Affiliate of Baxter IntlJul 23, 1998
K970679 · ALTRA FLUX 200 HEMODIALYZER
- Baxter Healthcare CorpMar 11, 1998
K970653 · CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
- Baxter Healthcare CorpMar 11, 1998
K970662 · CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)
- Baxter Healthcare CorpJan 11, 1998
K970663 · CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)
- Renal Systems, Inc.Jan 5, 1998
K970648 · PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)