InterValve Inc

FDA Regulatory Profile

InterValve Inc appears in FDA public data with 1 recall, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1621-2014, Class II) was initiated on Mar 14, 2014. Its most recent 510(k) clearance was granted on Dec 18, 2015.

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, 2328Mar 14, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K152150V8 Balloon Aortic Valvuloplasty CatheterDec 18, 2015
K150343V8 Transluminal BAV CatheterApr 3, 2015
K133607V8 TRANSLUMINAL BAV CATHETERFeb 11, 2014
K132728V8 TRANSLUMINAL BAV CATHETERNov 22, 2013
K123111V8 TRANSLUMINAL BAV CATHETERJan 31, 2013