FDA.reportPublic FDA data

510(k) K250632

Device
Arctx Cool Catheter Set
Applicant
Arctx Medical
510(k) number
K250632
Product code
PLA
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-30
Date received
2025-03-03
Regulation
870.5910
Classification name
Esophageal Thermal Regulation And Gastric Suctioning Device
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Don Gurskis
Address
5856 Farington Pl., Suite 200 Raleigh NC US 27609 27609

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PLA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233357EsoCool Thermal Regulation CatheterNuvaira, Inc.2024-06-27
K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical2018-05-17
K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical2018-02-28
K172029EnsoETMAttune Medical2018-01-05
K172493EnsoETMAttune Medical2017-10-17
K170009Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC2017-03-30
K152450Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC2016-01-15
DEN140018ESOPHAGEAL COOLING DEVICEAdvanced Cooling Therapy, LLC2015-06-23