# K250751: DualView Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corporation
- Decided: Jul 17, 2025 after 127 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: 4 generations back to K050577 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have 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 6.
- K123621: Opticross 40 MHZ Coronary Imaging Catheter, Boston Scientific Corp (2013) Summary page 6.

## Indications for use
DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

Source page: https://510kreport.com/device/K250751
Methodology: https://510kreport.com/methodology