# K192019: Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Nov 8, 2019 after 102 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K123369 (2013). 2 ancestors in all.
10 later devices descend from it; 3 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141769: Optis Integrated System, Dragonfly Optis Imaging Catheter, Lightlab Imaging, Inc. (2014) Summary page 4.

## Most influential descendants
- K221257: SpectraWAVE Imaging System (2023), 4 descendants of its own
- K210458: OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System (2021), 2 descendants of its own
- K230691: HyperVue™ Imaging System (2023), 1 descendant of its own
- K230411: Dragonfly OpStar™ Imaging Catheter (2023), 1 descendant of its own
- K253459: OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (2026), 0 descendants of its own

## Recalls of this device
- Mar 30, 2022 · Class I · Z-1095-2022: There is a potential that the proximal marker may separate from the imaging catheter

## Indications for use
The Dragonfly OpStar™ imaging catheter with 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. The AptiVue™ E-series software is intended for use only with compatible OPTIS™ imaging systems. The OPTIS imaging system with a compatible Dragonfly™ imaging catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly™ imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ imaging catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS imaging system is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

Source page: https://510kreport.com/device/K192019
Methodology: https://510kreport.com/methodology