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FDA 510(k)

Cook® Spectrum® 2 MRC Central Venous Catheter

K-Number: K223648 · 2023-02-03

ApplicantCook Advanced Technologies
Decision Date2023-02-03
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Cook Advanced Technologies. The 510(k) number is K223648.

When was Cook® Spectrum® 2 MRC Central Venous Catheter approved by the FDA?

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

What company makes Cook® Spectrum® 2 MRC Central Venous Catheter?

Cook® Spectrum® 2 MRC Central Venous Catheter is manufactured by Cook Advanced Technologies.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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