K183090 is an FDA 510(k) clearance for the Relieva Tract Balloon Dilation System. This device is classified as a Balloon, Nasal Airway (Class I - General Controls, product code QGK).
Submitted by Acclarent, Inc. (Irvin, US). The FDA issued a Cleared decision on April 19, 2019, 164 days after receiving the submission on November 6, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420. The Nasal Airway Balloon Is Intended To Provide Increased Intranasal Space To Facilitate Access For Endonasal And Transnasal Procedures And/or Temporarily Address Nasal Obstruction..
| 510(k) Number | K183090 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2018 |
| Decision Date | April 19, 2019 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | QGK — Balloon, Nasal Airway |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |
| Definition | The Nasal Airway Balloon Is Intended To Provide Increased Intranasal Space To Facilitate Access For Endonasal And Transnasal Procedures And/or Temporarily Address Nasal Obstruction. |