NuVent Eustachian Tube Dilation Balloon— 510(k) K210841
Substantially EquivalentMedtronic Xomed, Inc.
FDA 510(k) clearance K210841 for NuVent Eustachian Tube Dilation Balloon, Substantially Equivalent on 2021-08-16. Applicant: Medtronic Xomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Xomed, Inc.
- Product code
- Code PNZ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4180
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.