Approach CTO Microwire Guide
K-Number: K171897 · 2017-08-21
ApplicantCook Incorporated
Decision Date2017-08-21
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Approach CTO Microwire Guide is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-08-21 under approval number K171897. 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 Approach CTO Microwire Guide?
Approach CTO Microwire Guide is a medical device that received FDA 510(k) clearance on 2017-08-21. It is manufactured by Cook Incorporated. The 510(k) number is K171897.
When was Approach CTO Microwire Guide approved by the FDA?
Approach CTO Microwire Guide received FDA 510(k) clearance on 2017-08-21, under approval number K171897.
What company makes Approach CTO Microwire Guide?
Approach CTO Microwire Guide is manufactured by Cook Incorporated.
What is the FDA product code for Approach CTO Microwire Guide?
The FDA product code for Approach CTO Microwire 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.