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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 K230411
Device Name Dragonfly OpStar™ Imaging Catheter
Applicant
Abbott Medical
4 Robbins Road
Westford,  MA  01886
Applicant Contact Derek Pike
Correspondent
Abbott Medical
4 Robbins Road
Westford,  MA  01886
Correspondent Contact Mingzi Deng
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/15/2023
Decision Date 04/14/2023
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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