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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 Rd.
Westford,  MA  01886
Applicant Contact Derek Pike
Correspondent
Abbott Medical
4 Robbins Rd.
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
Predetermined Change
Control Plan Authorized		 No
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