K191313 is an FDA 510(k) clearance for the Unity Subcutaneous Infusion System for Remodulin. This device is classified as a Infusion Pump, Drug Specific, Pharmacy-filled (Class II - Special Controls, product code QJY).
Submitted by DEKA Research & Development (Manchester, US). The FDA issued a Cleared decision on February 21, 2020, 282 days after receiving the submission on May 15, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725. A Pharmacy-filled, Drug Specific Infusion System Is A Prescription Device Intended For Delivery Of A Specific Drug In Accordance With The Fda Approved Labeling And May Be Filled At A Location Other Than Point Of Care..
| 510(k) Number | K191313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2019 |
| Decision Date | February 21, 2020 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QJY - Infusion Pump, Drug Specific, Pharmacy-filled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
| Definition | A Pharmacy-filled, Drug Specific Infusion System Is A Prescription Device Intended For Delivery Of A Specific Drug In Accordance With The Fda Approved Labeling And May Be Filled At A Location Other Than Point Of Care. |