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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
Models AHW1430IJ, AHW14R001J
Device Name ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
Original Applicant
ASAHI INTECC CO., LTD.
2500 red hill ave, suite 210
santa ana,  CA  92705
Original Contact yoshi terai
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/13/2012
Decision Date 03/08/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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