K-number	K152194
Device name	transGlide Expandable Introducer
Applicant	Transaortic Medical, Inc.
Product code	DYB
Device class	Class II
Decision date	Apr 7, 2016
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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transGlide Expandable Introducer

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