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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 K060745
Device Name ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY
Applicant
Asahi Intecc Co., Ltd.
1301 Dove St., Suite #350
Newport Beach,  CA  92660
Applicant Contact YOSHI TERAI
Correspondent
Asahi Intecc Co., Ltd.
1301 Dove St., Suite #350
Newport Beach,  CA  92660
Correspondent Contact YOSHI TERAI
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/20/2006
Decision Date 06/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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