K254278
- 510(k) number
- K254278
- Device name
- Arterial Pressure Monitoring Set/Tray
- Applicant
- Spectrum Vascular NY · US
- Product code
- DQO — Catheter, Intravascular, Diagnostic
- Decision date
- 2026-03-25
- Date received
- 2025-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K254278.pdf
Official FDA record: K254278
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.