K231401
- 510(k) number
- K231401
- Device name
- Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
- Applicant
- Poly Medicure Limited IN
- Product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
- Decision date
- 2023-09-21
- Date received
- 2023-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K231401.pdf
Official FDA record: K231401
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.