510(k) Report

Devices descending from K160273

9 later devices reach truFreeze System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161557truFreeze SystemCSA Medical, Inc.20168—
+2K162695truFreeze SystemCSA Medical, Inc.20167—
+3K171522truFreeze Rapid AV Spray KitCSA Medical, Inc.20170—
+3K163244truFreeze SystemCSA Medical, Inc.20175—
+4K171626truFreeze SystemCSA Medical, Inc.20173—
+4K172041truFreeze SystemCSA Medical, Inc.20170—
+5K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20221—
+5K201183Vortex Radial Spray CatheterCSA Medical, Inc.20200—
+6K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20220—