NIFClass IIImplantLife-sustaining
Catheter, Hemodialysis, Triple Lumen, Implanted
Gastroenterology, Urology · 21 CFR 876.5540
Long-term (> 30 days) central venous access for hemodialysis, and apheresis, with a third lumen for infusion.
MDR events7All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
7 adverse event reports on file
- MAHURKARSep 18, 2018MalfunctionCovidien Llc7884692
- MAHURKARJun 9, 2017MalfunctionCovidien Mfg Solutions S.a.3009211636-2017-05161
- 14.5 FX 28 CM HEMO-FLOWJan 5, 2012MalfunctionMedcomp2518902-2012-00002
- HEMO- FLOW CATHETERAug 15, 2011MalfunctionMedcomp2518902-2011-00079
- 14.5F X 28 CM HEMO-FLOWAug 15, 2011MalfunctionMedcomp2518902-2011-00078
- 14.5FX28CM HEMO-FLOWJun 9, 2011MalfunctionMedcomp2518902-2011-00061
- 14.5FX28CM HEMO-FLOWMar 28, 2011MalfunctionMedcomp2518902-2011-00025
Event type breakdown
Malfunction7
Most-reported manufacturers
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
0 clearances for this product code
No 510(k) clearances on file for this product code.