InterValve Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1621-2014Class IIInterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 2328March 14, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K152150V8 Balloon Aortic Valvuloplasty CatheterDecember 18, 2015
K150343V8 Transluminal BAV CatheterApril 3, 2015
K133607V8 TRANSLUMINAL BAV CATHETERFebruary 11, 2014
K132728V8 TRANSLUMINAL BAV CATHETERNovember 22, 2013
K123111V8 TRANSLUMINAL BAV CATHETERJanuary 31, 2013