QXV · Class II · 21 CFR 870.5720

FDA Product Code QXV: Temperature Regulation Device For Esophageal Protection During Cardiac Ablation

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 Esophagus During Cardiac Ablation.

Leading manufacturers include Advanced Cooling Therapy, Inc. D/B/A Attune Medical.

1
Total
0
Cleared
167d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Temperature Regulation Device For Esophageal Protection During Cardiac Ablation Devices (Product Code QXV)

1 devices
1–1 of 1
Not Cleared Sep 13, 2023
ensoETM
DEN230021
Advanced Cooling Therapy, Inc. D/B/A Attune Medical
Cardiovascular · 167d

About Product Code QXV - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QXV since 2023, with 0 receiving FDA clearance (average review time: 167 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QXV devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →