FDA 510(k)

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

K-Number: K192019 · 2019-11-08

Decision Date2019-11-08

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K192019. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1?

Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K192019.

When did Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 receive FDA 510(k) clearance?

Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 received FDA 510(k) clearance on 2019-11-08, under 510(k) number K192019.

Who is the listed applicant for Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1?

The FDA product code for Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 is DQO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.