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510(k) K250632

Arctx Cool Catheter Set by Arctx Medical — Product Code PLA

K250632 is an FDA 510(k) premarket notification submitted by Arctx Medical for the device "Arctx Cool Catheter Set". The FDA issued a decision of Substantially Equivalent on Oct 30, 2025. The device falls under product code PLA (Esophageal Thermal Regulation And Gastric Suctioning Device), a Class II device regulated under 21 CFR 870.5910.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 30, 2025
Date Received
Mar 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 (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)
  • DEN140018 — ESOPHAGEAL COOLING DEVICE (Jun 23, 2015)

FDA data resources