510(k) Report

Devices descending from K062937

3 later devices reach Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181864Polaris RF Ablation SystemBaylis Medical Company, Inc.201906
+1K163236COOLIEF Cooled Radiofrequency KitHalyard Health, Inc.20161—
+2K203066COOLIEF Cooled Radiofrequency Kit AdvancedAvanos Medical, Inc.20200—