FDA 510(k)

Conjunto/Plato de Monitoreo de Presión Arterial

N.º K: K254278 · 2026-03-25

Fecha de decisión2026-03-25

Código de productoDQO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Arterial Pressure Monitoring Set/Tray is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Vascular. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K254278. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Arterial Pressure Monitoring Set/Tray?

Arterial Pressure Monitoring Set/Tray is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Spectrum Vascular. The 510(k) number is K254278.

When did Arterial Pressure Monitoring Set/Tray receive FDA 510(k) clearance?

Arterial Pressure Monitoring Set/Tray received FDA 510(k) clearance on 2026-03-25, under 510(k) number K254278.

Who is the listed applicant for Arterial Pressure Monitoring Set/Tray?

The FDA 510(k) record lists Spectrum Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arterial Pressure Monitoring Set/Tray?

The FDA product code for Arterial Pressure Monitoring Set/Tray is DQO.

Ensayos clínicos relacionados

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Otros registros que enlistan a Spectrum Vascular como solicitante

K260165Unimpregnated Central Venous Catheter K261455Conjunto/Plato de Monitoreo de Presión Arterial K252373BioFlo 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 K250724Intraosseous Infusion Needles K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter

Dispositivos relacionados (Código: DQO)

K261455Conjunto/Plato de Monitoreo de Presión ArterialSpectrum Vascular K252702Bioptimal 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, TD2602NBioptimal International Pte. , Ltd.K250751DualView CatheterTerumo Corporation K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC K242420pNOVUS 21 MicrocatheterPhenox, Ltd.K233268Impress Angiographic CatheterMerit Medical Systems, Inc.

Fuente oficial

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