Invatec Llc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1517-2013Class IIlnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manMarch 4, 2009

Recent 510(k) Clearances

K-NumberDeviceDate
K100921ADMIRAL XTREME PTA BALLOON DILATATION CATHETERApril 30, 2010
K092352SCUBA BILIARY STENT SYSTEMMarch 16, 2010
K092361REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETEROctober 29, 2009
K092177MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6October 15, 2009