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FDA 510(k)

Cobra Catheter System

K-Number: K223891 · 2023-02-15

Decision Date2023-02-15
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cobra Catheter System is a medical device manufactured by Endovascular Engineering. It received FDA 510(k) clearance on 2023-02-15 under approval number K223891. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cobra Catheter System?

Cobra Catheter System is a medical device that received FDA 510(k) clearance on 2023-02-15. It is manufactured by Endovascular Engineering. The 510(k) number is K223891.

When was Cobra Catheter System approved by the FDA?

Cobra Catheter System received FDA 510(k) clearance on 2023-02-15, under approval number K223891.

What company makes Cobra Catheter System?

Cobra Catheter System is manufactured by Endovascular Engineering.

What is the FDA product code for Cobra Catheter System?

The FDA product code for Cobra Catheter System is QEW.

Related Clinical Trials

Related Devices (Code: QEW)

Official Source

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