VasoNova, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1408-2015Class IIVasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: ThMarch 30, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K123813VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLEJanuary 18, 2013
K103255VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLETFebruary 18, 2011
K103260VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLEFebruary 18, 2011
K091924VPS CATHETERNovember 18, 2009
K083920FLOWPICC CATHETERMay 1, 2009
K082481FLOWPICC CATHETERDecember 17, 2008
K081626FLOWPICC CONSOLEOctober 15, 2008
K081625FLOWPICC STYLETSeptember 26, 2008