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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 K162563
Device Name YOGA Microcatheter
Applicant
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact YOON HEE BEATTY
Correspondent
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact YOON HEE BEATTY
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/14/2016
Decision Date 01/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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