Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
The esophageal protection device for use in percutaneous cardiac catheter ablation procedures via mechanical deviation (product code QXU) is a Class 2 Cardiovascular device (regulation 870.5710) placed in the esophageal lumen to reduce the likelihood of esophageal injury during cardiac ablation procedures by using mechanical means to deviate the esophagus away from the ablation energy source. It requires 510(k) clearance. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QXU
- Device Class
- FDA class 2
- Regulation Number
- 870.5710
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.