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510(k) DEN140018

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

DEN140018 is an FDA 510(k) premarket notification submitted by Advanced Cooling Therapy, LLC for the device "ESOPHAGEAL COOLING DEVICE". The FDA issued a decision of De Novo Granted on Jun 23, 2015. The device falls under product code PLA (Esophageal Thermal Regulation And Gastric Suctioning Device), a Class II device regulated under 21 CFR 870.5910. Advanced Cooling Therapy, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
Jun 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 (Mar 30, 2017)
  • K152450 — Esophageal Cooling Device (Jan 15, 2016)

Other clearances for product code PLA

  • K250632 — Arctx Cool Catheter Set (Oct 30, 2025)
  • K233357 — EsoCool Thermal Regulation Catheter (Jun 27, 2024)
  • K180742 — EnsoETM (May 17, 2018)
  • K180244 — EnsoETM (Feb 28, 2018)
  • K172029 — EnsoETM (Jan 5, 2018)
  • K172493 — EnsoETM (Oct 17, 2017)
  • K170009 — Esophageal Cooling Device (Mar 30, 2017)
  • K152450 — Esophageal Cooling Device (Jan 15, 2016)

FDA data resources