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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 K192599
Device Name ASAHI PTCA Guide Wire ASAHI Gaia Next
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-cho
seto,  JP 489-0071
Applicant Contact yasuyuki kawahara
Correspondent
Asahi Intecc USA, Inc.
3002 Dow Ave, Suite 212
tustin,  CA  92780
Correspondent Contact cynthia valenzuela
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/20/2019
Decision Date 01/02/2020
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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