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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2021-08-16 under 510(k) 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. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K210841.

When did NuVent Eustachian Tube Dilation Balloon receive FDA 510(k) clearance?

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

Who is the listed applicant for NuVent Eustachian Tube Dilation Balloon?

The FDA 510(k) record lists Medtronic Xomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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NCT07599826Active vs. Passive VR During Office-based ENT ProceduresNOT_YET_RECRUITINGNCT06967506Evaluation of Blowing Exercises Utilizing a Breathing Exercise Device in Otitis Media With EffusionCOMPLETED

Other records listing Medtronic Xomed, Inc. as applicant

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Related Devices (Code: PNZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbHK230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation SystemFiagon GmbHK220027Audion ET dilation systemEntellus Medical, Inc.K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.

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.

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