K250794
- 510(k) number
- K250794
- Device name
- InVera Infusion Device
- Applicant
- Invera Medical IE
- Product code
- KRA — Catheter, Continuous Flush
- Decision date
- 2026-03-12
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K250794.pdf
Official FDA record: K250794
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.