K253703
- 510(k) number
- K253703
- Device name
- RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
- Applicant
- Deka R&D Corp NH · US
- Product code
- FRN — Pump, Infusion
- Decision date
- 2026-07-24
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253703.pdf
Official FDA record: K253703
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.