Acclarent, Inc. · Class II · Cleared Mar 31, 2011
| K-number | K110218 |
| Device name | INSPIRA AIR BALLOON DILATION SYSTEM |
| Applicant | Acclarent, Inc. |
| Product code | KTI |
| Device class | Class II |
| Decision date | Mar 31, 2011 |
| Decision | Substantially Equivalent |
| Regulation | 874.4680 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov