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FDA 510(k)

ApexMV

K-Number: K182022 · 2019-03-15

ApplicantIncontrol Medical, LLC
Decision Date2019-03-15
Product CodeKPI
Advisory CommitteeGU
DecisionUnknown

Device Summary

ApexMV is a medical device manufactured by Incontrol Medical, LLC. It received FDA 510(k) clearance on 2019-03-15 under approval number K182022. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ApexMV?

ApexMV is a medical device that received FDA 510(k) clearance on 2019-03-15. It is manufactured by Incontrol Medical, LLC. The 510(k) number is K182022.

When was ApexMV approved by the FDA?

ApexMV received FDA 510(k) clearance on 2019-03-15, under approval number K182022.

What company makes ApexMV?

ApexMV is manufactured by Incontrol Medical, LLC.

What is the FDA product code for ApexMV?

The FDA product code for ApexMV is KPI.

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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.

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