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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K170914
Device Name TXM Support Catheter
Applicant
Texasmedical Technologies, Inc.
2118 Wilshire Blvd. #682
Santa Monica,  CA  90403
Applicant Contact Ed Anderson
Correspondent
Smith Associates
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/28/2017
Decision Date 11/21/2017
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
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