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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K181817
Device Name transGlideXT Expandable Introducer
Applicant
Transaortic Medical, Inc.
135 E. Main Ave., Suite 170
Morgan Hill,  CA  95037
Applicant Contact Richard Ginn
Correspondent
Transaortic Medical, Inc.
135 E. Main Ave., Suite 170
Morgan Hill,  CA  95037
Correspondent Contact Diana DeGregorio
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/09/2018
Decision Date 03/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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