K190182 is an FDA 510(k) clearance for the Unity Subcutaneous Delivery System for Remodulin. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by DEKA Research & Development (Manchester, US). The FDA issued a Cleared decision on May 6, 2019, 94 days after receiving the submission on February 1, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K190182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2019 |
| Decision Date | May 06, 2019 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN - Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |