# K193119: Twin-Pass Dual Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, LLC
- Decided: Jun 29, 2020 after 230 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: 1 generation back to K060327 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060327: Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter, Vascular Solutions, Inc. (2006) Summary page 4.

## Most influential descendants
- K240885: Shadow Catheter (2024), 0 descendants of its own

## Indications for use
The Twin-Pass 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/K193119
Methodology: https://510kreport.com/methodology