FDA Product Code QXU: Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
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 Mechanical Means To Deviate The Esophagus Away From The Source Of Ablation Energy
Leading manufacturers include S4 Medical Corp..
FDA 510(k) Cleared Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation Devices (Product Code QXU)
About Product Code QXU - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QXU since 2023, with 1 receiving FDA clearance (average review time: 128 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QXU have taken an average of 31 days to reach a decision - down from 225 days historically, suggesting improved FDA processing for this classification.
QXU devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →