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FDA 510(k)

Cook Unimpregnated Central Venous Catheter

K-Number: K182252 · 2019-05-17

ApplicantCook Incorporated
Decision Date2019-05-17
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Cook Unimpregnated Central Venous Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-05-17 under approval number K182252. 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 Unimpregnated Central Venous Catheter?

Cook Unimpregnated Central Venous Catheter is a medical device that received FDA 510(k) clearance on 2019-05-17. It is manufactured by Cook Incorporated. The 510(k) number is K182252.

When was Cook Unimpregnated Central Venous Catheter approved by the FDA?

Cook Unimpregnated Central Venous Catheter received FDA 510(k) clearance on 2019-05-17, under approval number K182252.

What company makes Cook Unimpregnated Central Venous Catheter?

Cook Unimpregnated Central Venous Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Cook Unimpregnated Central Venous Catheter?

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

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Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., Ltd.

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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