The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Nuvent Eustachian Tube Dilation Balloon.
| Device ID | K210841 |
| 510k Number | K210841 |
| Device Name: | NuVent Eustachian Tube Dilation Balloon |
| Classification | Eustachian Tube Balloon Dilation Device |
| Applicant | Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 |
| Contact | Matthew Harmon |
| Correspondent | Matthew Harmon Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 |
| Product Code | PNZ |
| CFR Regulation Number | 874.4180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-22 |
| Decision Date | 2021-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000416034 | K210841 | 000 |