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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K192782
Device Name ASAHI CROSSWALK Peripheral Support Catheter
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-cho
seto,  JP 489-0071
Applicant Contact yasuyuki kawuhara
Correspondent
Asahi Intecc USA, Inc.
3002 Dow Avenue, Suite 212
tustin,  CA  92780
Correspondent Contact cynthia valenzuela
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/30/2019
Decision Date 11/29/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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