MOUClass III
Intravascular Radiation Delivery System
Unknown
MDR events143All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances0All time
Recent MDR events
143 adverse event reports on file
- BETA-CATH SYSTEMJun 2, 2021InjuryBest Vascular, Inc.3000205626-2021-00001
- BEST VASCULAR INC NOVOSTE B-RAIL DELIVERY CATHMay 28, 2021InjuryBest Vascular IncMW5101623
- BETH CATH ACTIVE TRANSFER DEVICESep 27, 2019MalfunctionBest Vascular Inc9128812
- B-RAILFeb 2, 2015MalfunctionBest Vascular, Inc.4507759
- BETA-CATH 3.5F SYSTEMDec 23, 2014MalfunctionBest Vascular, Inc.4384678
- NOVOSTE B-RAILJul 2, 2013MalfunctionBest Vascular, Inc3225999
- NOVOSTE BETA-CATH IVBJun 12, 2013MalfunctionBest Vascular, Inc3208703
- SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUIDJun 20, 2008MalfunctionSmith & Nephew Inc., Endoscopy Div.1219602-2008-00146
- SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUIDJul 19, 2006MalfunctionSmith & Nephew, Inc. - Endoscopy Division1219602-2006-00100
- SURETAC RAPID DELIVERY SYSTEM W/O GLENOID GUIDEJun 23, 2006MalfunctionSmith & Nephew, Inc., Endoscopy Division1219602-2006-00091
Event type breakdown
Malfunction92
Other35
Injury7
Unspecified6
Death3
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
3 premarket approvals for this product code