K261530
- 510(k) number
- K261530
- Device name
- iiSure Infusion Set
- Applicant
- Deka Research and Development NH · US
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2026-06-03
- Date received
- 2026-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261530.pdf
Official FDA record: K261530
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.