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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 K153106
Device Name ASAHI Fielder XT-A, ASAHI Fielder XT-R
Applicant
Asahi Intecc Co., Ltd.
1703 Wakita-Cho, Moriyama-Ku
Hagoya-Shi,  JP 463-0024
Applicant Contact Yoshihiko Fukui
Correspondent
CardioMed Device Consultants, LLC
5523 Research Park Dr., Suite 205
Baltimore,  MD  21228
Correspondent Contact Candace Cederman
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/27/2015
Decision Date 06/21/2016
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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