FDA 510(k)

MC3 Vascular Access Kit 21030

K-Number: K182914 · 2018-10-29

Decision Date2018-10-29

Product CodeDRE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MC3 Vascular Access Kit 21030 is a medical device manufactured by Mc3 Incorporated. It received FDA 510(k) clearance on 2018-10-29 under approval number K182914. 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 MC3 Vascular Access Kit 21030?

MC3 Vascular Access Kit 21030 is a medical device that received FDA 510(k) clearance on 2018-10-29. It is manufactured by Mc3 Incorporated. The 510(k) number is K182914.

When was MC3 Vascular Access Kit 21030 approved by the FDA?

MC3 Vascular Access Kit 21030 received FDA 510(k) clearance on 2018-10-29, under approval number K182914.

What company makes MC3 Vascular Access Kit 21030?

MC3 Vascular Access Kit 21030 is manufactured by Mc3 Incorporated.

What is the FDA product code for MC3 Vascular Access Kit 21030?

The FDA product code for MC3 Vascular Access Kit 21030 is DRE.

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Other Devices by Mc3 Incorporated

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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.