FJTClass IILife-sustaining
Intracatheter, Dialysis
Gastroenterology, Urology · 21 CFR 876.5820
MDR events8All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances5All time
Recent MDR events
8 adverse event reports on file
- 20CM 12FR MAH HPTLC TRAY W/SENov 6, 2015MalfunctionCovidien3009211636-2015-00447
- MAHURKARMar 22, 2010InjuryKendall/tyco Healthcare Group1651892
- HEMOSPLIT CATHETEROct 6, 2003Malfunction*1720496-2003-00196
- HEMOSPLIT CATHETERAug 20, 2003MalfunctionBard Access Systems1720496-2003-00134
- BAXTERMar 1, 1999InjuryBaxter Healthcare Corp211970
- HICKMAN HEMODIALYSIS CATHETERJul 21, 1994MalfunctionBard9508
- PERMCATHApr 9, 1993MalfunctionVas-cath, Inc.5441
- PERMCATHApr 5, 1993MalfunctionVas-cath, Inc.5686
Event type breakdown
Malfunction6
Injury2
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
5 clearances for this product code
- National Medical Care, Medical Products Div., Inc.Sep 25, 1986
K863297 · MODIFICATION'S TO TORAY'S B-2 SERIES
- Sorensen ResearchNov 29, 1977
K772148 · CATHETER, FEMORAL VEIN, SF 6
- Sorensen ResearchNov 29, 1977
K772146 · CATHETER, VEIN, FEMORAL, SF 10
- Sorensen ResearchJan 14, 1977
K770047 · DNC 151 VINCA-FLO
- Extracorporeal Medical Specialities, Inc.Dec 6, 1976
K760781 · TRIEX-1 HOLLOW FIBER DIALYZER