# K031005: Lumend Frontrunner GW Cto Catheter

- Pathway: 510(k) (Special)
- Applicant: Lumend, Inc.
- Decided: Jun 18, 2003 after 79 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- 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 K935425 (1994). 8 ancestors in all.
32 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023223: Modification to Lumend Frontrunner Cto Catheter, Lumend, Inc. (2002) Summary page 1.
- K023114: Lumend Frontrunner Cto Catheter, Lumend, Inc. (2003) Summary page 1.

## Most influential descendants
- K033535: Lumend Frontrunner Cto Catheter and Accessories (2004), 31 descendants of its own
- K111338: Wildcat Catheter (2011), 17 descendants of its own
- K122380: Ocelot System (2012), 14 descendants of its own
- K123532: Ocelot Pixl Catheter (2012), 12 descendants of its own
- K102725: Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model M-3004 and M (2011), 11 descendants of its own

## Indications for use
The LuMend Frontrunner™ GW CTO Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.

Source page: https://510kreport.com/device/K031005
Methodology: https://510kreport.com/methodology