SentreHeart Inc

FDA Regulatory Profile

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
6
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0328-2017Class IFindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardSeptember 29, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K153096LARIAT RS Suture Delivery DeviceNovember 25, 2015
K142241LARIAT sulture Delivery DeviceSeptember 12, 2014
K090385LARIAT II SUTURE DELIVERY DEVICEMay 6, 2009
K080364FINDRWIRZ GUIDE WIRE SYSTEMAugust 11, 2008
K070126OCCLUSION BALLOON CATHETERFebruary 8, 2008
K060721LARIAT LOOP APPLICATORJune 2, 2006