ADAPT Tissue
K-Number: K200566 · 2020-04-03
ApplicantAdmedus Regen Pty, Ltd.
Decision Date2020-04-03
Product CodePSQ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ADAPT Tissue is a medical device manufactured by Admedus Regen Pty, Ltd.. It received FDA 510(k) clearance on 2020-04-03 under approval number K200566. The device is classified under product code PSQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ADAPT Tissue?
ADAPT Tissue is a medical device that received FDA 510(k) clearance on 2020-04-03. It is manufactured by Admedus Regen Pty, Ltd.. The 510(k) number is K200566.
When was ADAPT Tissue approved by the FDA?
ADAPT Tissue received FDA 510(k) clearance on 2020-04-03, under approval number K200566.
What company makes ADAPT Tissue?
ADAPT Tissue is manufactured by Admedus Regen Pty, Ltd..
What is the FDA product code for ADAPT Tissue?
The FDA product code for ADAPT Tissue is PSQ.
Related Clinical Trials
Other Devices by Admedus Regen Pty, Ltd.
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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.