The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Tract Balloon Dilation System.
| Device ID | K183090 |
| 510k Number | K183090 |
| Device Name: | Relieva Tract Balloon Dilation System |
| Classification | Balloon, Nasal Airway |
| Applicant | Acclarent, Inc. 33 Technology Drive Irvine, CA 92618 |
| Contact | Leena Sorathia |
| Correspondent | Leena Sorathia Acclarent, Inc. 33 Technology Drive Irvine, CA 92618 |
| Product Code | QGK |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-06 |
| Decision Date | 2019-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031462653 | K183090 | 000 |
| 20705031462639 | K183090 | 000 |
| 20705031462615 | K183090 | 000 |
| 20705031462592 | K183090 | 000 |
| 20705031462646 | K183090 | 000 |
| 20705031462622 | K183090 | 000 |
| 20705031462608 | K183090 | 000 |
| 20705031462585 | K183090 | 000 |