The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Sinus Balloon Catheter.
| Device ID | K061903 |
| 510k Number | K061903 |
| Device Name: | RELIEVA SINUS BALLOON CATHETER |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Keri Yen |
| Correspondent | Keri Yen ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-05 |
| Decision Date | 2006-08-18 |
| Summary: | summary |