Decision Date2017-07-21
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Progreat is a medical device manufactured by Ashitaka Factory of Terumo Corporation. It received FDA 510(k) clearance on 2017-07-21 under approval number K170223. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Progreat?
Progreat is a medical device that received FDA 510(k) clearance on 2017-07-21. It is manufactured by Ashitaka Factory of Terumo Corporation. The 510(k) number is K170223.
When was Progreat approved by the FDA?
Progreat received FDA 510(k) clearance on 2017-07-21, under approval number K170223.
What company makes Progreat?
Progreat is manufactured by Ashitaka Factory of Terumo Corporation.
What is the FDA product code for Progreat?
The FDA product code for Progreat is DQO.
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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.