# K240885: Shadow Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Simpson Interventions, Inc.
- Decided: Dec 19, 2024 after 262 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K060327 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193119: Twin-Pass Dual Access Catheter, Vascular Solutions, LLC (2020) Summary page 5.

## Indications for use
The Shadow Catheter™ is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

Source page: https://510kreport.com/device/K240885
Methodology: https://510kreport.com/methodology