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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 K122469
Device Name ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
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 Number870.1330
Classification Product Code
DQX  
Date Received08/13/2012
Decision Date 03/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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