Chrysalis Intelligence · Sponsors · Spectrum Vascular

Spectrum Vascular

White Plains, NY, US · 6 510(k) clearances

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Total clearances
6
2024-11-27 → 2026-08-10
Last 12 months
4
Product codes
4
Most recent
2026-08-10
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Class II General Hospital 2 2026-08-10
DQO — — — 2 2026-06-26
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days Class II General Hospital 1 2025-12-16
FMI Needle, Hypodermic, Single Lumen Class II General Hospital 1 2025-07-30
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2026-08-10 K260165 Unimpregnated Central Venous Catheter FOZ Class II General Hospital
2026-06-26 K261455 Arterial Pressure Monitoring Set/Tray DQO — —
2026-03-25 K254278 Arterial Pressure Monitoring Set/Tray DQO — —
2025-12-16 K252373 BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology LJS Class II General Hospital
2025-07-30 K250724 Intraosseous Infusion Needles FMI Class II General Hospital
2024-11-27 K241115 SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter FOZ Class II General Hospital
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence