K210841 is an FDA 510(k) clearance for the NuVent Eustachian Tube Dilation Balloon. This device is classified as 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 FDA review panel. Regulated under 21 CFR 874.4180. The Device Is Intended For Use In Dilating The Cartilaginous Portion Of The Eustachian Tube For Treating Persistent Eustachian Tube Dysfunction..
| 510(k) Number | K210841 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |