K061903 is an FDA 510(k) clearance for the RELIEVA SINUS BALLOON CATHETER. This device is classified as a Instrument, Ent Manual Surgical (Class I - General Controls, product code LRC).
Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on August 18, 2006, 44 days after receiving the submission on July 5, 2006.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K061903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2006 |
| Decision Date | August 18, 2006 |
| Days to Decision | 44 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LRC — Instrument, Ent Manual Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |