K241115
- 510(k) number
- K241115
- Device name
- SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
- Applicant
- Spectrum Vascular NY · US
- Product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Les
- Decision date
- 2024-11-27
- Date received
- 2024-04-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K241115.pdf
Official FDA record: K241115
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.