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Eustachian Tube Balloon Dilation Device

Eustachian Tube Balloon Dilation Device is a medical device type in the Ear, Nose, Throat specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Eustachian Tube Balloon Dilation Device
Ear, Nose, Throat Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PNZ

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Class 2

21 CFR 874.4180

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Ear, Nose, Throat

Device Characteristics

No

No

No

Not Eligible

Definition

The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.