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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 Rd.
Westford,  MA  01886
Applicant Contact Richard DeMello
Correspondent
Abbott Medical
4 Robbins Rd.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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