Kalila Medical

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0563-2018Class IIVado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is December 14, 2017
Z-0564-2018Class IIVado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a December 14, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K160721Vado Steerable SheathMarch 7, 2017
K162427Vado Bi-Directional Steerable SheathJanuary 27, 2017
K140420VADO STEERABLE SHEATHApril 1, 2014