# K060327: Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Apr 12, 2006 after 62 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
101 later devices descend from it; 7 cite it directly.
2 of 102 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) Pivot Steerable Microcatheter: named in the summary without a submission number
- (no number) Twin-Pass Dual Access Catheter: named in the summary without a submission number
- (no number) Skyway Support Catheter: named in the summary without a submission number
- (no number) Langston Dual Lumen Pressure Monitoring Catheter: named in the summary without a submission number

## Most influential descendants
- K070372: Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610 (2007), 44 descendants of its own
- K082337: Minnie Support Catheter (2009), 35 descendants of its own
- K083313: Wildcat 7F Guidewire Support Catheter (2009), 21 descendants of its own
- K091345: Gopher Gold Catheter, Model 5620 (2009), 20 descendants of its own
- K102022: Wildcat 6F Guidewire Support Catheter Model W400L and W400S (2010), 18 descendants of its own

## Recalls of this device
- Sep 16, 2016 · Class I · Z-0054-2017: 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 
- Jul 2, 2009 · Not classified · Z-1712-2009: Three occurrences of Twin-Pass catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used duri

## 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. The Skyway support catheters are intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The Skyway OTW also may be used to subselectively infuse/deliver therapeutic agents.

Source page: https://510kreport.com/device/K060327
Methodology: https://510kreport.com/methodology