FJGClass IILife-sustaining
Dialyzer, Parallel Flow
Gastroenterology, Urology · 21 CFR 876.5820
MDR events101All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances36All time
Recent MDR events
101 adverse event reports on file
- FILTRAL 20Mar 8, 2000InjuryHospal Industrie8010182-2000-00002
- FILTRAL 20Feb 9, 2000MalfunctionHospal Industrie8010182-2000-00001
- FILTRAL 20Dec 1, 1999InjuryHospal Industrie8010182-1999-00025
- FILTRAL 20Dec 1, 1999InjuryHospal Industrie8010182-1999-00027
- FILTRAL 20Dec 1, 1999InjuryHospal Industrie8010182-1999-00026
- AN-69Oct 10, 1999MalfunctionHospal Industrie8010182-1999-00023
- AN-69Oct 10, 1999MalfunctionHospal Industie8010182-1999-00022
- AN-69Oct 10, 1999MalfunctionHospal Industrie8010182-1999-00021
- AN-69Jul 31, 1999InjuryHospal Industrie8010182-1999-00017
- AN-69Jul 31, 1999InjuryHospal Industrie8010182-1999-00018
Event type breakdown
Injury46
Malfunction40
Unspecified10
Other4
Death1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
36 clearances for this product code
- Cobe Renal Care, Inc.Sep 7, 1994
K933681 · GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS
- Cobe Renal Care, Inc.Aug 26, 1994
K933680 · GAMBRO LUNDIA PRO 200 DIALYZER
- National Medical Care, Medical Products Div., Inc.Sep 21, 1992
K920693 · DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9
- C.G.H. Medical, Inc.Mar 6, 1992
K915504 · GAMBRO LUNDIA ALPHA HEMODIALYZERS
- Gambro-Hospal, Inc.Aug 2, 1990
K901368 · HEMOSPAL KITS A1, A2D, AO, & A1D
- Akcess Medical Products, Inc.Aug 1, 1990
K902203 · TENCKHOFF PERITONEAL DIALYSIS KIT
- Gambro, Inc.Sep 29, 1986
K862840 · GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N
- Gambro, Inc.Jan 8, 1986
K853406 · GAMBRO LUNDIA PRO 3 & 5 DIALYZER