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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, angioplasty, peripheral, transluminal
510(k) Number K160941
Device Name Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
Applicant
Brosmed Medical Co., Ltd.
15th Bldg., SMEs Venture Park, Songshan Lake
Hi-Tech Industrial Development
Dongguan,  CN 523808
Applicant Contact Tina Yin
Correspondent
Brosmed Medical Co., Ltd.
15th Bldg., SMEs Venture Park, Songshan Lake
Hi-Tech Industrial Development
Dongguan,  CN 523808
Correspondent Contact Tina Yin
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/04/2016
Decision Date 12/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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