# K023114: Lumend Frontrunner Cto Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Lumend, Inc.
- Decided: Jan 23, 2003 after 126 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: 3 generations back to K935425 (1994). 6 ancestors in all.
69 later devices descend from it; 3 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013284: Lumend Frontrunner Cto Coronary Catheter, Lumend, Inc. (2002) Summary page 1.

## Most influential descendants
- K040067: Clirpath Excimer Laser Catheter (2004), 36 descendants of its own
- K031005: Lumend Frontrunner GW Cto Catheter (2003), 32 descendants of its own
- K033535: Lumend Frontrunner Cto Catheter and Accessories (2004), 31 descendants of its own
- K043465: 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011 (2005), 25 descendants of its own
- K052296: Clirpath Turbo Excimer Laser Catheters (2005), 24 descendants of its own

## Indications for use
The LuMend Frontrunner™ 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/K023114
Methodology: https://510kreport.com/methodology