Pirouette High Pressure (HP)
K-Number: K172033 · 2017-08-31
ApplicantArravasc, Ltd.
Decision Date2017-08-31
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Pirouette High Pressure (HP) is a medical device manufactured by Arravasc, Ltd.. It received FDA 510(k) clearance on 2017-08-31 under approval number K172033. 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 High Pressure (HP)?
Pirouette High Pressure (HP) is a medical device that received FDA 510(k) clearance on 2017-08-31. It is manufactured by Arravasc, Ltd.. The 510(k) number is K172033.
When was Pirouette High Pressure (HP) approved by the FDA?
Pirouette High Pressure (HP) received FDA 510(k) clearance on 2017-08-31, under approval number K172033.
What company makes Pirouette High Pressure (HP)?
Pirouette High Pressure (HP) is manufactured by Arravasc, Ltd..
What is the FDA product code for Pirouette High Pressure (HP)?
The FDA product code for Pirouette High Pressure (HP) 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.