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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 K133177
Device Name MODIFIED HD GUIDE CATHETER
Applicant
Concentric Medical, Inc.
301 E. Evelyn Ave.
Mountain View,  CA  94041
Applicant Contact RHODA SANTOS
Correspondent
Concentric Medical, Inc.
301 E. Evelyn Ave.
Mountain View,  CA  94041
Correspondent Contact RHODA SANTOS
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
DQO  
Date Received10/17/2013
Decision Date 02/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01088672
NCT01270867
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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