Decision Date2021-04-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Plato 17 Microcatheter is a medical device manufactured by Scientia Vascular, LLC. It received FDA 510(k) clearance on 2021-04-28 under approval number K210601. 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 Plato 17 Microcatheter?
Plato 17 Microcatheter is a medical device that received FDA 510(k) clearance on 2021-04-28. It is manufactured by Scientia Vascular, LLC. The 510(k) number is K210601.
When was Plato 17 Microcatheter approved by the FDA?
Plato 17 Microcatheter received FDA 510(k) clearance on 2021-04-28, under approval number K210601.
What company makes Plato 17 Microcatheter?
Plato 17 Microcatheter is manufactured by Scientia Vascular, LLC.
What is the FDA product code for Plato 17 Microcatheter?
The FDA product code for Plato 17 Microcatheter is DQY.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.