510(k) clearances for Esophageal Thermal Regulation And Gastric Suctioning Device
9 on file
- Arctx MedicalOct 30, 2025
K250632 · Arctx Cool Catheter Set
- Nuvaira, Inc.Jun 27, 2024
K233357 · EsoCool Thermal Regulation Catheter
- Advanced Cooling Therapy, Inc. D/B/A Attune MedicalMay 17, 2018
K180742 · EnsoETM
- Advanced Cooling Therapy, Inc. D/B/A Attune MedicalFeb 28, 2018
K180244 · EnsoETM
- Attune MedicalJan 5, 2018
K172029 · EnsoETM
- Attune MedicalOct 17, 2017
K172493 · EnsoETM
- Advanced Cooling Therapy, LLCMar 30, 2017
K170009 · Esophageal Cooling Device
- Advanced Cooling Therapy, LLCJan 15, 2016
K152450 · Esophageal Cooling Device
- Advanced Cooling Therapy, LLCJun 23, 2015
DEN140018 · ESOPHAGEAL COOLING DEVICE