transGlide Expandable Introducer
K-Number: K152194 · 2016-04-07
ApplicantTransaortic Medical, Inc.
Decision Date2016-04-07
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
transGlide Expandable Introducer is a medical device manufactured by Transaortic Medical, Inc.. It received FDA 510(k) clearance on 2016-04-07 under approval number K152194. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the transGlide Expandable Introducer?
transGlide Expandable Introducer is a medical device that received FDA 510(k) clearance on 2016-04-07. It is manufactured by Transaortic Medical, Inc.. The 510(k) number is K152194.
When was transGlide Expandable Introducer approved by the FDA?
transGlide Expandable Introducer received FDA 510(k) clearance on 2016-04-07, under approval number K152194.
What company makes transGlide Expandable Introducer?
transGlide Expandable Introducer is manufactured by Transaortic Medical, Inc..
What is the FDA product code for transGlide Expandable Introducer?
The FDA product code for transGlide Expandable Introducer is DYB.
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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.