510(k) Report

Devices descending from K161557

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

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