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FDA 510(k)

Royal Flush Plus High-Flow Catheter

K-Number: K180054 · 2018-10-05

ApplicantCook Incorporated
Decision Date2018-10-05
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Royal Flush Plus High-Flow Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-10-05 under approval number K180054. 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 Plus High-Flow Catheter?

Royal Flush Plus High-Flow Catheter is a medical device that received FDA 510(k) clearance on 2018-10-05. It is manufactured by Cook Incorporated. The 510(k) number is K180054.

When was Royal Flush Plus High-Flow Catheter approved by the FDA?

Royal Flush Plus High-Flow Catheter received FDA 510(k) clearance on 2018-10-05, under approval number K180054.

What company makes Royal Flush Plus High-Flow Catheter?

Royal Flush Plus High-Flow Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Royal Flush Plus High-Flow Catheter?

The FDA product code for Royal Flush Plus High-Flow Catheter is 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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