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FDA 510(k)

Pirouette 014

K-Number: K162316 · 2016-11-22

ApplicantArravasc, Ltd.
Decision Date2016-11-22
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pirouette 014 is the device name listed in this FDA 510(k) record. The listed applicant is Arravasc, Ltd.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) 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. The listed applicant is Arravasc, Ltd.. The 510(k) number is K162316.

When did Pirouette 014 receive FDA 510(k) clearance?

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

Who is the listed applicant for Pirouette 014?

The FDA 510(k) record lists Arravasc, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pirouette 014?

The FDA product code for Pirouette 014 is LIT.

Other records listing Arravasc, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172033Pirouette High Pressure (HP)K161427Pirouette 035

Related Devices (Code: LIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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