K252398
- 510(k) number
- K252398
- Device name
- SURFLO Hybria Closed System Safety IV Catheter
- Applicant
- Terumo Medical Products (Hangzhou) Co., Ltd. CN
- Product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
- Decision date
- 2025-12-17
- Date received
- 2025-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K252398.pdf
Official FDA record: K252398
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.