Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NuVent Eustachian Tube Dilation Balloon

K-Number: K210841 · 2021-08-16

ApplicantMedtronic Xomed, Inc.
Decision Date2021-08-16
Product CodePNZ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NuVent Eustachian Tube Dilation Balloon is a medical device manufactured by Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2021-08-16 under approval number K210841. The device is classified under product code PNZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVent Eustachian Tube Dilation Balloon?

NuVent Eustachian Tube Dilation Balloon is a medical device that received FDA 510(k) clearance on 2021-08-16. It is manufactured by Medtronic Xomed, Inc.. The 510(k) number is K210841.

When was NuVent Eustachian Tube Dilation Balloon approved by the FDA?

NuVent Eustachian Tube Dilation Balloon received FDA 510(k) clearance on 2021-08-16, under approval number K210841.

What company makes NuVent Eustachian Tube Dilation Balloon?

NuVent Eustachian Tube Dilation Balloon is manufactured by Medtronic Xomed, Inc..

What is the FDA product code for NuVent Eustachian Tube Dilation Balloon?

The FDA product code for NuVent Eustachian Tube Dilation Balloon is PNZ.

Related Clinical Trials

NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN NCT07599826 Active vs. Passive VR During Office-based ENT Procedures NOT_YET_RECRUITING NCT07583706 A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia RECRUITING NCT06964373 Cervical Ripening Balloons for Same-Day Cervical Prep RECRUITING NCT06967506 Evaluation of Blowing Exercises Utilizing a Breathing Exercise Device in Otitis Media With Effusion COMPLETED NCT03791970 Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries RECRUITING

Other Devices by Medtronic Xomed, Inc.

K173855Sharpsite AC Rigid Endsocope K200759NIM Vital, Nerve Integrity Monitor K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long K230320NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube K231580NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)

View all 7 devices →

Related Devices (Code: PNZ)

DEN150056Acclarent Aera Eustachian Tube Balloon Dilation SystemAcclarent, Inc. K163509XprESS ENT Dilation SystemEntellus Medical, Inc. K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. K220027Audion ET dilation systemEntellus Medical, Inc. K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc. K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑