510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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DEN230021Unknown

ensoETM

Advanced Cooling Therapy, Inc. D/B/A Attune Medical, Chicago IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN230021 is the FDA 510(k) clearance record for ensoETM, a class II device, cleared for Advanced Cooling Therapy, Inc. D/B/A Attune Medical on under FDA product code QXV (Temperature Regulation Device For Esophageal Protection During Cardiac Ablation). FDA's definition for product code QXV reads: "This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses temperature regulation to control the temperature of the...". FDA records list 3 510(k) clearances for Advanced Cooling Therapy, Inc. D/B/A Attune Medical, from to . As of , FDA records show no recalls naming DEN230021.

Clearance record

Decision date
Received
(167 days to decision)
Product code
QXV Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
Regulation
21 CFR 870.5720
Device class
Class II
Review panel
Cardiovascular
Applicant
Advanced Cooling Therapy, Inc. D/B/A Attune Medical 3440 S. Dearborn St., Chicago IL
Third party review
No

Clearances, product code QXV

Trailing 12 months

FDA records hold no clearances under product code QXV in the trailing twelve months.

FDA records show no clearances under product code QXV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260