FKAClass II
Dilator, Vessel
Gastroenterology, Urology · 21 CFR 876.5540
MDR events5All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances3All time
Recent MDR events
5 adverse event reports on file
- 13 X 75 MM X 4.0 ML BD VACUTAINER® PLUS LAVENDER BD HEMOGARD¿ CLOSUREJul 26, 2017MalfunctionBecton, Dickinson & Co.1917413-2017-00072
- 16X125MM 8.0 ML BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBEJul 21, 2017MalfunctionBecton, Dickinson & Co.1917413-2017-00042
- HEMOSPLIT CATHETERJan 19, 2012MalfunctionC. R. Bard Inc. (basd)3006260740-2012-00021
- VASCULAR PROBEJul 25, 2006MalfunctionSynovis Surgical Innovations2183620-2006-00015
- HYDROSTATIC BALLOON DILATORMay 2, 1996InjuryBoston Scientific Corp.MW1009001
Event type breakdown
Malfunction4
Injury1
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
3 clearances for this product code