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Spectrum Vascular

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories4
Latest FDA decision2026-08-10
TypeNumberDevice NameCodeDateActions
510(k) K260165 Unimpregnated Central Venous CatheterFOZ2026-08-10 View
510(k) K261455 Arterial Pressure Monitoring Set/TrayDQO2026-06-26 View
510(k) K254278 Arterial Pressure Monitoring Set/TrayDQO2026-03-25 View
510(k) 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 TechnologyLJS2025-12-16 View
510(k) K250724 Intraosseous Infusion NeedlesFMI2025-07-30 View
510(k) K241115 SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous CatheterFOZ2024-11-27 View
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