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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 K161362
Device Name ASAHI Corsair Armet
Applicant
Asahi Intecc Co., Ltd.
1703 Wakita-cho, Moriyama-Ku
nagoya,  JP 463-0024
Applicant Contact carroll councilman
Correspondent
CardioMed Device Consultants, LLC
5523 Research Park Drive, Suite 205
baltimore,  MD  21228
Correspondent Contact candace cederman
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/16/2016
Decision Date 06/14/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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