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FDA 510(k)

Emergency Transtracheal Airway Catheter

K-Number: K153761 · 2016-09-22

ApplicantCook Incorporated
Decision Date2016-09-22
Product CodeBWC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Emergency Transtracheal Airway Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-09-22 under approval number K153761. The device is classified under product code BWC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emergency Transtracheal Airway Catheter?

Emergency Transtracheal Airway Catheter is a medical device that received FDA 510(k) clearance on 2016-09-22. It is manufactured by Cook Incorporated. The 510(k) number is K153761.

When was Emergency Transtracheal Airway Catheter approved by the FDA?

Emergency Transtracheal Airway Catheter received FDA 510(k) clearance on 2016-09-22, under approval number K153761.

What company makes Emergency Transtracheal Airway Catheter?

Emergency Transtracheal Airway Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Emergency Transtracheal Airway Catheter?

The FDA product code for Emergency Transtracheal Airway Catheter is BWC.

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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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