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FDA 510(k)

InVera Infusion Device

K-Number: K250794 · 2026-03-12

ApplicantInvera Medical
Decision Date2026-03-12
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

InVera Infusion Device is a medical device manufactured by Invera Medical. It received FDA 510(k) clearance on 2026-03-12 under approval number K250794. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InVera Infusion Device?

InVera Infusion Device is a medical device that received FDA 510(k) clearance on 2026-03-12. It is manufactured by Invera Medical. The 510(k) number is K250794.

When was InVera Infusion Device approved by the FDA?

InVera Infusion Device received FDA 510(k) clearance on 2026-03-12, under approval number K250794.

What company makes InVera Infusion Device?

InVera Infusion Device is manufactured by Invera Medical.

What is the FDA product code for InVera Infusion Device?

The FDA product code for InVera Infusion Device is KRA.

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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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