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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 K182420
Device Name ASAHI Corsair Pro XS
Asahi Intecc Co., Ltd.
3-100 Akatsuki-cho
seto,  JP 489-0071
Applicant Contact yasuyuki kawahara
Cardiomed Device Consultants, LLC
3168 Braverton Street, Suite 200
edgewater,  MD  21037
Correspondent Contact candace cederman
Regulation Number870.1250
Classification Product Code
Date Received09/05/2018
Decision Date 12/20/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No