510(k) Report

Devices descending from K170009

5 later devices reach Esophageal Cooling Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172029EnsoETMAttune Medical20182—
+1K172493EnsoETMAttune Medical20172—
+2K233357EsoCool Thermal Regulation CatheterNuvaira, Inc.20240—
+2K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical20180—
+2K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical20181—