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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 K083127
Device Name ASAHI CORSAIR MICROCATHETER
Applicant
Asahi Intecc Co., Ltd.
2500 Red Hill Ave.
Suite 210
Santa Ana,  CA  92705
Applicant Contact YOSHI TERAI
Correspondent
Asahi Intecc Co., Ltd.
2500 Red Hill Ave.
Suite 210
Santa Ana,  CA  92705
Correspondent Contact YOSHI TERAI
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/21/2008
Decision Date 02/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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