# K033535: Lumend Frontrunner Cto Catheter and Accessories

- Pathway: 510(k) (Special)
- Applicant: Lumend, Inc.
- Decided: Jan 7, 2004 after 58 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: 5 generations back to K935425 (1994). 9 ancestors in all.
31 later devices descend from it; 3 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)
- K031005: Lumend Frontrunner GW Cto Catheter, Lumend, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K140185: Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console (2014), 7 descendants of its own

## Indications for use
The LuMend Frontrunner® CTO Catheter and Accessories are intended to facilitate the intraluminal placemcnt of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to fusther percutaneous intervention.

Source page: https://510kreport.com/device/K033535
Methodology: https://510kreport.com/methodology