K252677
- 510(k) number
- K252677
- Device name
- Polyshield Safety IV Catheters
- Applicant
- Poly Medicure Limited IN
- Product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
- Decision date
- 2025-11-05
- Date received
- 2025-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K252677.pdf
Official FDA record: K252677
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.