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FDA 510(k)

Royal Flush Catheter

K-Number: K171264 · 2018-01-25

ApplicantCook Incorporated
Decision Date2018-01-25
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Royal Flush Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-01-25 under approval number K171264. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Royal Flush Catheter?

Royal Flush Catheter is a medical device that received FDA 510(k) clearance on 2018-01-25. It is manufactured by Cook Incorporated. The 510(k) number is K171264.

When was Royal Flush Catheter approved by the FDA?

Royal Flush Catheter received FDA 510(k) clearance on 2018-01-25, under approval number K171264.

What company makes Royal Flush Catheter?

Royal Flush Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Royal Flush Catheter?

The FDA product code for Royal Flush Catheter is DQO.

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Related Devices (Code: DQO)

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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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