K232987
- 510(k) number
- K232987
- Device name
- FlowArt Valve for Vial Access
- Applicant
- Asset Medikal Tasarim Sanayi VE Ticaret A.S. TR
- Product code
- LHI — Set, I.V. Fluid Transfer
- Decision date
- 2024-06-26
- Date received
- 2023-09-22
- 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: K232987
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.