Lumax Guiding Catheter
K-Number: K191163 · 2019-12-12
ApplicantCook Incorporated
Decision Date2019-12-12
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Lumax Guiding Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-12-12 under approval number K191163. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Lumax Guiding Catheter?
Lumax Guiding Catheter is a medical device that received FDA 510(k) clearance on 2019-12-12. It is manufactured by Cook Incorporated. The 510(k) number is K191163.
When was Lumax Guiding Catheter approved by the FDA?
Lumax Guiding Catheter received FDA 510(k) clearance on 2019-12-12, under approval number K191163.
What company makes Lumax Guiding Catheter?
Lumax Guiding Catheter is manufactured by Cook Incorporated.
What is the FDA product code for Lumax Guiding Catheter?
The FDA product code for Lumax Guiding Catheter is DQY.
Related Clinical Trials
Other Devices by Cook Incorporated
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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.