Mandril Wire Guide
K-Number: K171997 · 2018-03-30
ApplicantCook Incorporated
Decision Date2018-03-30
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Mandril Wire Guide is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-03-30 under approval number K171997. 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 Mandril Wire Guide?
Mandril Wire Guide is a medical device that received FDA 510(k) clearance on 2018-03-30. It is manufactured by Cook Incorporated. The 510(k) number is K171997.
When was Mandril Wire Guide approved by the FDA?
Mandril Wire Guide received FDA 510(k) clearance on 2018-03-30, under approval number K171997.
What company makes Mandril Wire Guide?
Mandril Wire Guide is manufactured by Cook Incorporated.
What is the FDA product code for Mandril Wire Guide?
The FDA product code for Mandril 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.