The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Ultirranav Sinus Balloon Catheter.
| Device ID | K161698 |
| 510k Number | K161698 |
| Device Name: | Relieva UltirraNav Sinus Balloon Catheter |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | ACCLARENT, INC. 33 TECHNOLOGY DRIVE Irvine, CA 92618 |
| Contact | James Patrick Garvey |
| Correspondent | James Patrick Garvey ACCLARENT, INC. 33 TECHNOLOGY DRIVE Irvine, CA 92618 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-20 |
| Decision Date | 2016-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031238708 | K161698 | 000 |