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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 K122468
Models AHW14R004J, AHW14R004S, AHW14R304J, AHW14R304S
Device Name ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO
Applicant
ASAHI INTECC CO., LTD.
2500 red hill suite 210
santa ana,,  CA  92705
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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