# K072618: Twin-Pass Otw Catheter, Model 5201

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Nov 21, 2007 after 65 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 K052257 (2005). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052257: Vascular Solutions Twin-Pass Dual Access Catheter, Vascular Solutions, Inc. (2005) Summary page 1.
- K060327: Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter, Vascular Solutions, Inc. (2006) Summary page 2.

## Most influential descendants
- K121763: Multicross Support Catheter (2012), 8 descendants of its own
- K140910: Centercross Catheter (2014), 3 descendants of its own
- K152456: CenterCross Ultra Catheter (2016), 2 descendants of its own
- K143608: NovaCross Microcatheter (2015), 2 descendants of its own
- K160681: CenterCross Ultra Catheter (2016), 1 descendant of its own

## Indications for use
The TwinPass OTW Catheter is to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement 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/K072618
Methodology: https://510kreport.com/methodology