K-number	K192019
Device name	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1
Applicant	ABBOTT MEDICAL
Product code	DQO
Device class	Class II
Decision date	Nov 8, 2019
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1

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Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1