Endovascular Dilator and Sets
K-Number: K210734 · 2021-04-06
ApplicantCook Incorporated
Decision Date2021-04-06
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Endovascular Dilator and Sets is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2021-04-06 under approval number K210734. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Endovascular Dilator and Sets?
Endovascular Dilator and Sets is a medical device that received FDA 510(k) clearance on 2021-04-06. It is manufactured by Cook Incorporated. The 510(k) number is K210734.
When was Endovascular Dilator and Sets approved by the FDA?
Endovascular Dilator and Sets received FDA 510(k) clearance on 2021-04-06, under approval number K210734.
What company makes Endovascular Dilator and Sets?
Endovascular Dilator and Sets is manufactured by Cook Incorporated.
What is the FDA product code for Endovascular Dilator and Sets?
The FDA product code for Endovascular Dilator and Sets is DRE.
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.