510(k) Report

Devices descending from K150920

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152668truFreeze SystemCSA Medical, Inc.201510—
+2K160273truFreeze SystemCsa Medial, Inc.20169—
+3K161557truFreeze SystemCSA Medical, Inc.20168—
+4K162695truFreeze SystemCSA Medical, Inc.20167—
+5K171522truFreeze Rapid AV Spray KitCSA Medical, Inc.20170—
+5K163244truFreeze SystemCSA Medical, Inc.20175—
+6K171626truFreeze SystemCSA Medical, Inc.20173—
+6K172041truFreeze SystemCSA Medical, Inc.20170—
+7K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20221—
+7K201183Vortex Radial Spray CatheterCSA Medical, Inc.20200—
+8K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20220—