FDA 510(k)

Dragonfly OpStar Imaging Catheter

K-Number: K230411 · 2023-04-14

Decision Date2023-04-14

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Dragonfly OpStar Imaging Catheter is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2023-04-14 under approval number K230411. 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?

Dragonfly OpStar Imaging Catheter is a medical device that received FDA 510(k) clearance on 2023-04-14. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K230411.

When was Dragonfly OpStar Imaging Catheter approved by the FDA?

Dragonfly OpStar Imaging Catheter received FDA 510(k) clearance on 2023-04-14, under approval number K230411.

What company makes Dragonfly OpStar Imaging Catheter?

Dragonfly OpStar Imaging Catheter is manufactured by ABBOTT MEDICAL.

What is the FDA product code for Dragonfly OpStar Imaging Catheter?

The FDA product code for Dragonfly OpStar Imaging Catheter is DQO.

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Official Source

View on FDA Database →

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