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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K232573
Device Name INFINITI™ Ambi Angiographic Catheter
Applicant
Cordis US Corp.
14201 North West 60th Avenue
Miami Lakes,  FL  33014
Applicant Contact Zheng Wang
Correspondent
Cordis US Corp.
14201 North West 60th Avenue
Miami Lakes,  FL  33014
Correspondent Contact Zheng Wang
Regulation Number870.1200
Classification Product Code
DQO  
Date Received08/25/2023
Decision Date 11/21/2023
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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