FDA 510(k)

Cook® Spectrum® 2 MRC Central Venous Catheter

Número K: K223648 · 2023-02-03

Data da decisão2023-02-03

Código do produtoFOZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cook® Spectrum® 2 MRC Central Venous Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Advanced Technologies. It received FDA 510(k) clearance on 2023-02-03 under 510(k) number K223648. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cook® Spectrum® 2 MRC Central Venous Catheter?

Cook® Spectrum® 2 MRC Central Venous Catheter is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Cook Advanced Technologies. The 510(k) number is K223648.

When did Cook® Spectrum® 2 MRC Central Venous Catheter receive FDA 510(k) clearance?

Cook® Spectrum® 2 MRC Central Venous Catheter received FDA 510(k) clearance on 2023-02-03, under 510(k) number K223648.

Who is the listed applicant for Cook® Spectrum® 2 MRC Central Venous Catheter?

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

What is the FDA product code for Cook® Spectrum® 2 MRC Central Venous Catheter?

The FDA product code for Cook® Spectrum® 2 MRC Central Venous Catheter is FOZ.

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