FDA 510(k)

14F Duo-Flow® Cateter de Doble Lumeno Lado a Lado

Número K: K250836 · 2025-08-12

Data da decisão2025-08-12

Código do produtoMPB

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

14F Duo-Flow® Side X Side Double Lumen Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K250836. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 14F Duo-Flow® Side X Side Double Lumen Catheter?

14F Duo-Flow® Side X Side Double Lumen Catheter is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Medical Components, Inc.. The 510(k) number is K250836.

When did 14F Duo-Flow® Side X Side Double Lumen Catheter receive FDA 510(k) clearance?

14F Duo-Flow® Side X Side Double Lumen Catheter received FDA 510(k) clearance on 2025-08-12, under 510(k) number K250836.

Who is the listed applicant for 14F Duo-Flow® Side X Side Double Lumen Catheter?

The FDA 510(k) record lists Medical Components, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 14F Duo-Flow® Side X Side Double Lumen Catheter?

The FDA product code for 14F Duo-Flow® Side X Side Double Lumen Catheter is MPB.

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Dispositivos Relacionados (Código: MPB)

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Fonte oficial

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