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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 K202252
Device Name ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-Cho
seto,  JP 489-0071
Applicant Contact yasuyuki kawahara
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 Received08/10/2020
Decision Date 09/08/2020
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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