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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 K213315
Device Name CROSSLEAD Peripheral Guide Wire
Applicant
Asahi Intecc Co., LTD.
3-100 Akatsuki-Cho
Seto,  JP 489-0071
Applicant Contact Tomoya Eguchi
Correspondent
Asahi Intecc USA, Inc.
3002 Dow Avenue, Suite 212
Tustin,  CA  92780
Correspondent Contact Cynthia Valenzuela
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/04/2021
Decision Date 07/01/2022
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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