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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
Asahi Intecc Co., Ltd.
1703 Wakita-cho, Moriyama-Ku
nagoya,  JP 463-0024
Applicant Contact carroll councilman
CardioMed Device Consultants, LLC
5523 Research Park Drive, Suite 205
baltimore,  MD  21228
Correspondent Contact candace cederman
Regulation Number870.1250
Classification Product Code
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