The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Spinplus Balloon Sinuplasty System.
| Device ID | K143541 |
| 510k Number | K143541 |
| Device Name: | Relieva SpinPlus Balloon Sinuplasty System |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DRIVE Menlo Park, CA 94025 |
| Contact | Pavan Sethi |
| Correspondent | Pavan Sethi ACCLARENT, INC. 1525-B O'BRIEN DRIVE 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 | 2014-12-15 |
| Decision Date | 2015-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031233062 | K143541 | 000 |
| 20705031232836 | K143541 | 000 |
| 20705031232850 | K143541 | 000 |
| 20705031232874 | K143541 | 000 |
| 20705031232911 | K143541 | 000 |
| 20705031232935 | K143541 | 000 |
| 20705031233031 | K143541 | 000 |
| 20705031233055 | K143541 | 000 |
| 20705031232812 | K143541 | 000 |
| 20705031232829 | K143541 | 000 |
| 20705031232843 | K143541 | 000 |
| 20705031232867 | K143541 | 000 |
| 20705031232904 | K143541 | 000 |
| 20705031232928 | K143541 | 000 |
| 20705031233048 | K143541 | 000 |
| 20705031232386 | K143541 | 000 |