# K191163: Lumax Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Dec 12, 2019 after 225 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: 4 generations back to K033633 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132409: Concierge Guiding Catheter, Merit Medical Systems, Inc. (2013) Summary page 4.

## Indications for use
Intended for the intravascular introduction of interventional devices into the peripheral, including pulmonary, vasculature.

Source page: https://510kreport.com/device/K191163
Methodology: https://510kreport.com/methodology