FDA.reportPublic FDA data

510(k) K233357

Device
EsoCool Thermal Regulation Catheter
Applicant
Nuvaira, Inc.
510(k) number
K233357
Product code
PLA
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-27
Date received
2023-09-29
Regulation
870.5910
Classification name
Esophageal Thermal Regulation And Gastric Suctioning Device
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
John Carline
Address
6500 Wedgewood N., Suite 100 Maple Grove, MN US 55311 55311

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
K250632Arctx Cool Catheter SetArctx Medical2025-10-30
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