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FDA 510(k) Application Details - K142817
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K142817
Device Name
Catheter, Intravascular, Diagnostic
Applicant
TEXAS MEDICAL TECHNOLOGIES, INC.
9005 Montana Ave., Suite A
El Paso, TX 79925 US
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Contact
Aaron Chiu
Other 510(k) Applications for this Contact
Regulation Number
870.1200
More FDA Info for this Regulation Number
Classification Product Code
DQO
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More FDA Info for this Product Code
Date Received
09/29/2014
Decision Date
04/23/2015
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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