K251854
- 510(k) number
- K251854
- Device name
- SteadiSet infusion set
- Applicant
- Tandem Diabetes Care CA · US
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2025-08-06
- Date received
- 2025-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251854.pdf
Official FDA record: K251854
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.