The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Solo Elite Sinus Balloon Catheter.
| Device ID | K111254 |
| 510k Number | K111254 |
| Device Name: | RELIEVA SOLO ELITE SINUS BALLOON CATHETER |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Kim Ky |
| Correspondent | Kim Ky ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-04 |
| Decision Date | 2011-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031200293 | K111254 | 000 |
| 20705031200286 | K111254 | 000 |
| 20705031200279 | K111254 | 000 |
| 20705031200255 | K111254 | 000 |