# K052257: Vascular Solutions Twin-Pass Dual Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Nov 23, 2005 after 97 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 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)
- None. The FDA summary names its predicate without a number.
- (no number) Lumend Percutaneous Catheter: named in the summary without a submission number
- (no number) Quick-Cross Catheter: named in the summary without a submission number
- (no number) Dual Lumen Catheter: named in the summary without a submission number

## Most influential descendants
- K072618: Twin-Pass Otw Catheter, Model 5201 (2007), 10 descendants of its own
- 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

## Recalls of this device
- Sep 16, 2016 · Class I · Z-0053-2017: Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the 

## Indications for use
The Twin-Pass Dual Access 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, and for use during two guidewire procedures.

Source page: https://510kreport.com/device/K052257
Methodology: https://510kreport.com/methodology