FDA 510(k)

Pirouette 014

K-Number: K162316 · 2016-11-22

Decision Date2016-11-22

Product CodeLIT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Pirouette 014 is a medical device manufactured by Arravasc, Ltd.. It received FDA 510(k) clearance on 2016-11-22 under approval number K162316. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pirouette 014?

Pirouette 014 is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Arravasc, Ltd.. The 510(k) number is K162316.

When was Pirouette 014 approved by the FDA?

Pirouette 014 received FDA 510(k) clearance on 2016-11-22, under approval number K162316.

What company makes Pirouette 014?

Pirouette 014 is manufactured by Arravasc, Ltd..

What is the FDA product code for Pirouette 014?

The FDA product code for Pirouette 014 is LIT.

Other Devices by Arravasc, Ltd.

K172033Pirouette High Pressure (HP)

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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.