K243841
- 510(k) number
- K243841
- Device name
- Sparta Infusion Set for Insulin
- Applicant
- Deka Research and Development NH · US
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2025-08-01
- Date received
- 2024-12-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K243841.pdf
Official FDA record: K243841
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.