# K112082: Guideliner V2 Catheter

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Dec 1, 2011 after 133 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K935425 (1994). 13 ancestors in all.
12 later devices descend from it; 3 cite it directly.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091750: Guideliner Catheter, Models 5571, 5572, 5573, Vascular Solutions, Inc. (2009) Summary page 1.

## Most influential descendants
- K172090: GuideLiner V3 Catheter (2017), 8 descendants of its own
- K183353: Telescope Guide Extension Catheter (2019), 3 descendants of its own
- K242276: CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) (2024), 1 descendant of its own
- K220691: LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension (2022), 1 descendant of its own
- K210110: Guidion (2021), 1 descendant of its own

## Recalls of this device
- Jan 17, 2012 · Not classified · Z-1655-2012: Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating f

## Indications for use
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guidewires and other interventional devices.

Source page: https://510kreport.com/device/K112082
Methodology: https://510kreport.com/methodology