Arterial Pressure Monitoring Set/Tray— 510(k) K254278
Substantially EquivalentSpectrum Vascular
FDA 510(k) clearance K254278 for Arterial Pressure Monitoring Set/Tray, Substantially Equivalent on 2026-03-25. Applicant: Spectrum Vascular. Device class: 2.
Summary
Spectrum Vascular's Arterial Pressure Monitoring Set/Tray is filed under DQO, diagnostic intravascular catheters. The name is generic, and the record doesn't list set or tray contents.
Class II, 21 CFR 870.1200. Cardiovascular is both the classification panel and the review panel. It was a Special 510(k).
Spectrum Vascular filed from White Plains, New York. The decision came 85 calendar days after receipt (December 30, 2025 to March 25, 2026).
Clearance details
- Applicant
- Spectrum Vascular
- Product code
- Product code DQO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- White Plains, NY, US
Recent devices under product code DQO
view all- K261455 — Arterial Pressure Monitoring Set/Tray
- K252702 — Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
- K250751 — DualView Catheter
- K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
- K242420 — pNOVUS 21 Microcatheter
More clearances from Spectrum Vascular
view allAdverse events under product code DQO
product code DQO- Death
- 35
- Injury
- 993
- Malfunction
- 1,772
- Other
- 5
- Total
- 2,805
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.