# K112100: M2 Navigation Catheter and Guideliner Navigation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Mar 20, 2012 after 242 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: 7 generations back to K935425 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 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.

## Indications for use
Navigation 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 of guidewires and other interventional devices.

Source page: https://510kreport.com/device/K112100
Methodology: https://510kreport.com/methodology