FDA.reportPublic FDA data

De Novo DEN230006

Device
esolution
Contact
william fuller
De Novo number
DEN230006
Product code
QXU
Regulation
870.5710
Classification name
esophageal protection device for use in percutaneous cardiac catheter ablation procedures, mechanical deviation
Decision
granted (DENG)
Decision date
2023-09-06
Date received
2023-01-24
Classification advisory
Cardiovascular
Review advisory
Cardiovascular
Type
Direct

Current FDA Classification#

Product code
QXU
Device name
Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
Medical specialty
Cardiovascular
Device class
2
Regulation
870.5710
Implant
N
Life sustain/support
N