FDA.reportPublic FDA data

De Novo DEN140018

Device
ESOPHAGEAL COOLING DEVICE
Contact
erik kulstad
De Novo number
DEN140018
Product code
PLA
Regulation
870.5910
Classification name
esophageal thermal regulation and gastric suctioning device
Decision
granted (DENG)
Decision date
2015-06-23
Date received
2014-05-09
Classification advisory
Cardiovascular
Review advisory
Cardiovascular
Type
Direct

Current FDA Classification#

Product code
PLA
Device name
Esophageal Thermal Regulation And Gastric Suctioning Device
Medical specialty
Cardiovascular
Device class
2
Regulation
870.5910
Implant
N
Life sustain/support
N