K260165
- 510(k) number
- K260165
- Device name
- Unimpregnated Central Venous Catheter
- Applicant
- Spectrum Vascular NY · US
- Product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
- Decision date
- 2026-08-10
- Date received
- 2026-01-20
- 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: K260165.pdf
Official FDA record: K260165
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.