Cardiosolutions

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K140015CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCERFebruary 5, 2014
K131332CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCERJuly 19, 2013
K120086CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CMApril 24, 2012
K094048PERCUPRO MESSENGER BALLOON CATHETERJuly 14, 2011
K094062PERCU-PRO GUIDEWIRESeptember 27, 2010