Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set

K-Number: K160200 · 2017-02-17

ApplicantCook Incorporated
Decision Date2017-02-17
Product CodeBWC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-02-17 under approval number K160200. 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 Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set?

Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set is a medical device that received FDA 510(k) clearance on 2017-02-17. It is manufactured by Cook Incorporated. The 510(k) number is K160200.

When was Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set approved by the FDA?

Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set received FDA 510(k) clearance on 2017-02-17, under approval number K160200.

What company makes Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set?

Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set is manufactured by Cook Incorporated.

What is the FDA product code for Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set?

The FDA product code for Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set is BWC.

Related Clinical Trials

NCT05948878 An Innovative Taping Technique for Improved Intravenous (IV) Catheter Securement COMPLETED NCT07516145 Robotic Transjugular Transcatheter Tricuspid Valve Replacement RECRUITING

Other Devices by Cook Incorporated

K160884CXI Support Catheter K161822Torcon NB Advantage Catheters K161496Turbo-Flo PICC Sets K160217uVue HSG/SHG Catheter K161002Aprima Smartesis Centesis Pump K153761Emergency Transtracheal Airway Catheter

View all 147 devices →

Related Devices (Code: BWC)

K153761Emergency Transtracheal Airway CatheterCook Incorporated K200190ScalpelCricVBM Medizintechnik GmbH

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.

↑