K181546 is an FDA 510(k) clearance for the Dillard Nasal Balloon Catheter. This device is classified as a Instrument, Ent Manual Surgical (Class I - General Controls, product code LRC).
Submitted by Intuit Medical Products, LLC (Sugar Hill, US). The FDA issued a Cleared decision on January 3, 2020, 570 days after receiving the submission on June 12, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K181546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2018 |
| Decision Date | January 03, 2020 |
| Days to Decision | 570 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 |