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 a medical device manufactured by Arravasc Limited. It received FDA 510(k) clearance on 2016-07-30 under approval 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. It is manufactured by Arravasc Limited. The 510(k) number is K161427.
When was Pirouette 035 approved by the FDA?
Pirouette 035 received FDA 510(k) clearance on 2016-07-30, under approval number K161427.
What company makes Pirouette 035?
Pirouette 035 is manufactured by Arravasc Limited.
What is the FDA product code for Pirouette 035?
The FDA product code for Pirouette 035 is LIT.
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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.