K111254 is an FDA 510(k) clearance for the RELIEVA SOLO ELITE 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 22, 2011, 110 days after receiving the submission on May 4, 2011.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K111254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2011 |
| Decision Date | August 22, 2011 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| 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 |