FDA 510(k)

Unimpregnated Central Venous Catheter

N.º K: K260165 · 2026-08-10

Fecha de decisión2026-08-10

Código de productoFOZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Unimpregnated Central Venous Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Vascular. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K260165. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Unimpregnated Central Venous Catheter?

Unimpregnated Central Venous Catheter is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Spectrum Vascular. The 510(k) number is K260165.

When did Unimpregnated Central Venous Catheter receive FDA 510(k) clearance?

El Catéter Veno Central Sin Impregnar recibió la aprobación FDA 510(k) el 10 de agosto de 2026, bajo el número de 510(k) K260165.

Who is the listed applicant for Unimpregnated Central Venous Catheter?

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 Unimpregnated Central Venous Catheter?

The FDA product code for Unimpregnated Central Venous Catheter is FOZ.

Ensayos clínicos relacionados

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Otros registros que enlistan a Spectrum Vascular como solicitante

K261455Conjunto/Plato de Monitoreo de Presión Arterial K254278Conjunto/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: FOZ)

K260432Ruby Intravascular CatheterVenocare, Inc.K261041ClearSafe Closed SystemMedSource Labs, LLC K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited

Fuente oficial

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