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FDA 510(k)

Plexus

K-Number: K191107 · 2019-08-27

ApplicantAlleva Medical (D.G), Ltd.
Decision Date2019-08-27
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Plexus is a medical device manufactured by Alleva Medical (D.G), Ltd.. It received FDA 510(k) clearance on 2019-08-27 under approval number K191107. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Plexus?

Plexus is a medical device that received FDA 510(k) clearance on 2019-08-27. It is manufactured by Alleva Medical (D.G), Ltd.. The 510(k) number is K191107.

When was Plexus approved by the FDA?

Plexus received FDA 510(k) clearance on 2019-08-27, under approval number K191107.

What company makes Plexus?

Plexus is manufactured by Alleva Medical (D.G), Ltd..

What is the FDA product code for Plexus?

The FDA product code for Plexus is JOW.

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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.

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