transGlideXT Expandable Introducer
K-Number: K181817 · 2019-03-26
ApplicantTransaortic Medical, Inc.
Decision Date2019-03-26
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
transGlideXT Expandable Introducer is a medical device manufactured by Transaortic Medical, Inc.. It received FDA 510(k) clearance on 2019-03-26 under approval number K181817. 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 transGlideXT Expandable Introducer?
transGlideXT Expandable Introducer is a medical device that received FDA 510(k) clearance on 2019-03-26. It is manufactured by Transaortic Medical, Inc.. The 510(k) number is K181817.
When was transGlideXT Expandable Introducer approved by the FDA?
transGlideXT Expandable Introducer received FDA 510(k) clearance on 2019-03-26, under approval number K181817.
What company makes transGlideXT Expandable Introducer?
transGlideXT Expandable Introducer is manufactured by Transaortic Medical, Inc..
What is the FDA product code for transGlideXT Expandable Introducer?
The FDA product code for transGlideXT 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.