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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K061984
Device Name TREASURE
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 Number870.1330
Classification Product Code
DQX  
Date Received07/13/2006
Decision Date 10/05/2006
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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