The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Spinplus Nav Balloon Sinuplasty System.
| Device ID | K171687 |
| 510k Number | K171687 |
| Device Name: | Relieva SpinPlus Nav Balloon Sinuplasty System |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | Acclarent, Inc. 33 Technology Drive Irvine, CA 92618 |
| Contact | James Patrick Garvey Ii |
| Correspondent | James Patrick Garvey Ii 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 | 2017-06-07 |
| Decision Date | 2017-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031245430 | K171687 | 000 |
| 20705031245423 | K171687 | 000 |
| 20705031241012 | K171687 | 000 |
| 20705031241005 | K171687 | 000 |