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510(k) K250632

Arctx Cool Catheter Set by Arctx Medical — Product Code PLA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2025
Date Received
March 3, 2025
Clearance Type
Traditional
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 for product code PLA

  • 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)
  • DEN140018 — ESOPHAGEAL COOLING DEVICE (June 23, 2015)