K252543
- 510(k) number
- K252543
- Device name
- AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- Applicant
- Amsino International, Inc. CA · US
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2026-05-04
- Date received
- 2025-08-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252543.pdf
Official FDA record: K252543
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.