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510(k) K180244

Device
EnsoETM
Applicant
Advanced Cooling Therapy, Inc. D/b/a Attune Medical
510(k) number
K180244
Product code
PLA  
Decision
Substantially Equivalent (SESE)
Decision date
2018-02-28
Date received
2018-01-29
Regulation
870.5910
Classification name
Esophageal Thermal Regulation And Gastric Suctioning Device
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Erik Kulstad
Address
3440 S. Dearborn St. #215-South Chicago IL US 60616 60616

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
K233357EsoCool Thermal Regulation CatheterNuvaira, Inc.2024-06-27
K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical2018-05-17
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

Legacy Summary#

summary

FDA Review#

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