# K230411: Dragonfly OpStar™ Imaging Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Apr 14, 2023 after 58 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K123369 (2013). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192019: Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1, Abbott Medical (2019) Summary page 4.

## Most influential descendants
- K242098: Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) (2025), 0 descendants of its own

## Indications for use
The Dragonfly OpStar™ Imaging Catheter with the OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

Source page: https://510kreport.com/device/K230411
Methodology: https://510kreport.com/methodology