FDA 510(k)

Bullfrog Micro-Infusion Device

K-Number: K161402 · 2016-08-18

Decision Date2016-08-18

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Bullfrog Micro-Infusion Device is a medical device manufactured by Mercator Medsystems, Inc.. It received FDA 510(k) clearance on 2016-08-18 under approval number K161402. 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 Bullfrog Micro-Infusion Device?

Bullfrog Micro-Infusion Device is a medical device that received FDA 510(k) clearance on 2016-08-18. It is manufactured by Mercator Medsystems, Inc.. The 510(k) number is K161402.

When was Bullfrog Micro-Infusion Device approved by the FDA?

Bullfrog Micro-Infusion Device received FDA 510(k) clearance on 2016-08-18, under approval number K161402.

What company makes Bullfrog Micro-Infusion Device?

Bullfrog Micro-Infusion Device is manufactured by Mercator Medsystems, Inc..

What is the FDA product code for Bullfrog Micro-Infusion Device?

The FDA product code for Bullfrog Micro-Infusion Device is KRA.

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Other Devices by Mercator Medsystems, Inc.

K153501Bullfrog Micro-Infusion Device K210339Bullfrog Micro-Infusion Device

Related Devices (Code: KRA)

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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.