510(k) Report

Devices descending from K162695

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

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