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FDA 510(k)

VSI Micro-Introducer Kit

K-Number: K180913 · 2018-05-09

Decision Date2018-05-09
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VSI Micro-Introducer Kit is a medical device manufactured by Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2018-05-09 under approval number K180913. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VSI Micro-Introducer Kit?

VSI Micro-Introducer Kit is a medical device that received FDA 510(k) clearance on 2018-05-09. It is manufactured by Vascular Solutions, Inc.. The 510(k) number is K180913.

When was VSI Micro-Introducer Kit approved by the FDA?

VSI Micro-Introducer Kit received FDA 510(k) clearance on 2018-05-09, under approval number K180913.

What company makes VSI Micro-Introducer Kit?

VSI Micro-Introducer Kit is manufactured by Vascular Solutions, Inc..

What is the FDA product code for VSI Micro-Introducer Kit?

The FDA product code for VSI Micro-Introducer Kit is DYB.

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Official Source

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