Trivascular, Inc

FDA Regulatory Profile

Summary

Total Recalls
3 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0125-2015Class IOvation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular OvatiSeptember 20, 2014
Z-1297-2014Class IIOvation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. SaFebruary 27, 2014
Z-0288-2013Class IITriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model NuOctober 19, 2012