K052198 is an FDA 510(k) clearance for the RELIEVA SINUS BALLOON INFLATION DEVICE. 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 31, 2005, 19 days after receiving the submission on August 12, 2005.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K052198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2005 |
| Decision Date | August 31, 2005 |
| Days to Decision | 19 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 |