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PLA — Esophageal Thermal Regulation And Gastric Suctioning Device Class II

FDA Device Classification

Classification Details

Product Code
PLA
Device Class
Class II
Regulation Number
870.5910
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250632arctx medicalArctx Cool Catheter SetOctober 30, 2025
K233357nuvairaEsoCool Thermal Regulation CatheterJune 27, 2024
K180742advanced cooling therapy, inc. d/b/a attune medicalEnsoETMMay 17, 2018
K180244advanced cooling therapy, inc. d/b/a attune medicalEnsoETMFebruary 28, 2018
K172029attune medicalEnsoETMJanuary 5, 2018
K172493attune medicalEnsoETMOctober 17, 2017
K170009advanced cooling therapyEsophageal Cooling DeviceMarch 30, 2017
K152450advanced cooling therapyEsophageal Cooling DeviceJanuary 15, 2016
DEN140018advanced cooling therapyESOPHAGEAL COOLING DEVICEJune 23, 2015