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510(k) DEN140018

ESOPHAGEAL COOLING DEVICE by Advanced Cooling Therapy, LLC — Product Code PLA

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
June 23, 2015
Date Received
May 9, 2014
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Esophageal Thermal Regulation And Gastric Suctioning Device
Device Class
Class II
Regulation Number
870.5910
Review Panel
CV
Submission Type

The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.

Other clearances by Advanced Cooling Therapy, LLC

  • K170009 — Esophageal Cooling Device (March 30, 2017)
  • K152450 — Esophageal Cooling Device (January 15, 2016)

Other clearances for product code PLA

  • K250632 — Arctx Cool Catheter Set (October 30, 2025)
  • K233357 — EsoCool Thermal Regulation Catheter (June 27, 2024)
  • K180742 — EnsoETM (May 17, 2018)
  • K180244 — EnsoETM (February 28, 2018)
  • K172029 — EnsoETM (January 5, 2018)
  • K172493 — EnsoETM (October 17, 2017)
  • K170009 — Esophageal Cooling Device (March 30, 2017)
  • K152450 — Esophageal Cooling Device (January 15, 2016)