K250357
- 510(k) number
- K250357
- Device name
- RemunityPRO Pump for Remodulin® (treprostinil) Injection
- Applicant
- Deka Research & Development Corp. NH · US
- Product code
- FRN — Pump, Infusion
- Decision date
- 2025-03-11
- Date received
- 2025-02-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250357.pdf
Official FDA record: K250357
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.