510(k) K191313
K191313 is an FDA 510(k) premarket notification submitted by DEKA Research & Development for the device "Unity Subcutaneous Infusion System for Remodulin". The FDA issued a decision of Substantially Equivalent on February 21, 2020. The device falls under product code QJY (Infusion Pump, Drug Specific, Pharmacy-Filled), a Class II device regulated under 21 CFR 880.5725. DEKA Research & Development has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2020
- Date Received
- May 15, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Infusion Pump, Drug Specific, Pharmacy-Filled
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type
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.