510(k) Report

Devices descending from DEN140018

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170009Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC20175—
+1K152450Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC20165—
+2K172029EnsoETMAttune Medical20182—
+2K172493EnsoETMAttune Medical20172—
+3K233357EsoCool Thermal Regulation CatheterNuvaira, Inc.20240—
+3K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical20180—
+3K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical20181—