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510(k) K210841

Device
NuVent Eustachian Tube Dilation Balloon
Applicant
Medtronic Xomed, Inc.
510(k) number
K210841
Product code
PNZ  
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-16
Date received
2021-03-22
Regulation
874.4180
Classification name
Eustachian Tube Balloon Dilation Device
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Matthew Harmon
Address
6743 Southpoint Dr. N. Jacksonville FL US 32216 32216

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.2026-02-19
K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.2023-12-13
K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH2023-08-03
K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation SystemFiagon GmbH2023-05-26
K220027Audion ET dilation systemEntellus Medical, Inc.2022-04-12
K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.2018-01-16
K163509XprESS ENT Dilation SystemEntellus Medical, Inc.2017-04-05
DEN150056Acclarent Aera Eustachian Tube Balloon Dilation SystemAcclarent, Inc.2016-09-16

Legacy Summary#

summary

FDA Review#

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