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FDA 510(k) Application Details - K152194
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K152194
Device Name
Introducer, Catheter
Applicant
TRANSAORTIC MEDICAL, INC.
135 E. MAIN AVE., SUITE 170
MORGAN HILL, CA 95037 US
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Contact
RICHARD GINN
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
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More FDA Info for this Product Code
Date Received
08/05/2015
Decision Date
04/07/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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