K250292
- 510(k) number
- K250292
- Device name
- OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
- Applicant
- Skydance Vascular, Inc. UT · US
- Product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
- Decision date
- 2025-05-02
- Date received
- 2025-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250292.pdf
Official FDA record: K250292
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.