K242339
- 510(k) number
- K242339
- Device name
- Intravascular Extension Sets and Accessories
- Applicant
- Baxter Healthcare Corporation IL · US
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2025-02-28
- Date received
- 2024-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242339.pdf
Official FDA record: K242339
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.