Advanced Cooling Therapy, LLC

FDA Device Registration & Listing · Boston, MA, US · Registration 3010412492

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010412492
FEI Number
3010412492
Entity Name
Advanced Cooling Therapy, LLC
City/State/Country
Boston, MA, US
Establishment Address
125 Summer St, Boston, MA 02110, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Advanced Cooling Therapy, LLC d/b/a "Attune Medical" (Owner Number: 10044486)
Owner / Operator Contact Address
125 Summer St, Boston, MA 02110, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K180244
PMA Number
N/A

All Registered Proprietary Names

ensoETM EnsoETM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PLA Esophageal Thermal Regulation And Gastric Suctioning Device Cardiovascular Class 2 870.5910 2023-11-01
QXV Temperature Regulation Device For Esophageal Protection During Cardiac Ablation Cardiovascular Class 2 870.5720 2023-11-01
PLA Esophageal Thermal Regulation And Gastric Suctioning Device Cardiovascular Class 2 870.5910 2018-04-26

Official Correspondent

Julie Ryan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Advanced Cooling Therapy, LLC d/b/a "Attune Medical"
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010412492. Last updated year: 2026. Please use registration number 3010412492 when referencing this establishment in official correspondence.
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