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FDA 510(k)

Pirouette 035

K-Number: K161427 · 2016-07-30

ApplicantArravasc Limited
Decision Date2016-07-30
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pirouette 035 is the device name listed in this FDA 510(k) record. The listed applicant is Arravasc Limited. It received FDA 510(k) clearance on 2016-07-30 under 510(k) number K161427. 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 035?

Pirouette 035 is a medical device that received FDA 510(k) clearance on 2016-07-30. The listed applicant is Arravasc Limited. The 510(k) number is K161427.

When did Pirouette 035 receive FDA 510(k) clearance?

Pirouette 035 received FDA 510(k) clearance on 2016-07-30, under 510(k) number K161427.

Who is the listed applicant for Pirouette 035?

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

What is the FDA product code for Pirouette 035?

The FDA product code for Pirouette 035 is LIT.

Other records listing Arravasc Limited 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)K162316Pirouette 014

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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