Submission Details
| 510(k) Number | K210841 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 22, 2021 |
| Decision Date | August 16, 2021 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
NuVent Eustachian Tube Dilation Balloon
Aug 2021
Decision
147d
Days
Class 2
Risk
About This 510(k) Submission
K210841 is an FDA 510(k) clearance for the NuVent Eustachian Tube Dilation Balloon, a Eustachian Tube Balloon Dilation Device (Class II — Special Controls, product code PNZ), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 16, 2021, 147 days after receiving the submission on March 22, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4180.
Device Classification
| Product Code | PNZ — Eustachian Tube Balloon Dilation Device |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.4180 |
| Definition | The Device Is Intended For Use In Dilating The Cartilaginous Portion Of The Eustachian Tube For Treating Persistent Eustachian Tube Dysfunction. |
Manufacturer
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