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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 K192019
Device Name Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
Applicant
Abbott Medical
4 Robbins Road
Westford,  MA  01886
Applicant Contact Richard DeMello
Correspondent
Abbott Medical
4 Robbins Road
Westford,  MA  01886
Correspondent Contact Richard DeMello
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
NQQ  
Date Received07/29/2019
Decision Date 11/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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