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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-09-22 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K153761.

When did Emergency Transtracheal Airway Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Emergency Transtracheal Airway Catheter?

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

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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