# K062877: Twin-Pass .023 Dual Access Catheter, Model 5230

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Jan 18, 2007 after 114 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K810412 (1981). 8 ancestors in all.
No later device cites it as a predicate yet.
4 of 9 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 2.
- K061565: Langston Dual Lumen Catheter, Vascular Solutions, Inc. (2006) Summary page 2.

## Recalls of this device
- Sep 16, 2016 · Class I · Z-0055-2017: 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 .023" catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral 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. The Twin-Pass .023" catheter is additionally intended to be used to measure intra-arterial pressure within the peripheral and coronary vasculature.

Source page: https://510kreport.com/device/K062877
Methodology: https://510kreport.com/methodology