K251715
- 510(k) number
- K251715
- Device name
- FlowArt® Vial Access Device Vented
- Applicant
- Asset Medikal TR
- Product code
- LHI — Set, I.V. Fluid Transfer
- Decision date
- 2025-10-14
- Date received
- 2025-06-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K251715
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.