Roadrunner Extra Support Wire Guide
K-Number: K183467 · 2019-01-11
ApplicantCook Incorporated
Decision Date2019-01-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Roadrunner Extra Support Wire Guide is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-01-11 under approval number K183467. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Roadrunner Extra Support Wire Guide?
Roadrunner Extra Support Wire Guide is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by Cook Incorporated. The 510(k) number is K183467.
When was Roadrunner Extra Support Wire Guide approved by the FDA?
Roadrunner Extra Support Wire Guide received FDA 510(k) clearance on 2019-01-11, under approval number K183467.
What company makes Roadrunner Extra Support Wire Guide?
Roadrunner Extra Support Wire Guide is manufactured by Cook Incorporated.
What is the FDA product code for Roadrunner Extra Support Wire Guide?
The FDA product code for Roadrunner Extra Support Wire Guide is DQX.
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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.