TransGlideXT Expandable Introducer

Introducer, Catheter

TransAortic Medical, Inc.

The following data is part of a premarket notification filed by Transaortic Medical, Inc. with the FDA for Transglidext Expandable Introducer.

Pre-market Notification Details

Device IDK181817
510k NumberK181817
Device Name:TransGlideXT Expandable Introducer
ClassificationIntroducer, Catheter
Applicant TransAortic Medical, Inc. 135 E. Main Ave., Suite 170 Morgan Hill,  CA  95037
ContactRichard Ginn
CorrespondentDiana Degregorio
TransAortic Medical, Inc. 135 E. Main Ave., Suite 170 Morgan Hill,  CA  95037
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-09
Decision Date2019-03-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000233815 K181817 000

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