K143738 is an FDA 510(k) clearance for the DSS Sinusplasty 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 August 27, 2015, 240 days after receiving the submission on December 30, 2014.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K143738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2014 |
| Decision Date | August 27, 2015 |
| Days to Decision | 240 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 |