# K214106: QuikPass Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Traverse Vascular, Inc.
- Decided: Jan 28, 2022 after 30 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: 8 generations back to K001992 (2000). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142065: Turnpike Catheter, Vascular Solutions, Inc. (2014) Summary page 4.

## Indications for use
The QuikPass Catheter is intended to be used to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and is also intended to assist in the delivery of contrast media into the coronary and/or peripheral vasculature.

Source page: https://510kreport.com/device/K214106
Methodology: https://510kreport.com/methodology