# K013284: Lumend Frontrunner Cto Coronary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Lumend, Inc.
- Decided: Feb 11, 2002 after 132 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: 2 generations back to K935425 (1994). 5 ancestors in all.
72 later devices descend from it; 3 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991059: Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support Catheter, Model 518-017, Spectranetics Corp. (1999) Summary page 1.
- K911547: Magnum-Meier Recanalization Guidewire, Schneider Intl., Ltd. (1991) Summary page 1.
- K970528: Clyde Coronary Guidewire, Schneider (Europe) GmbH (1997) Summary page 1.
- K884647: Usci Adjustable Tip Guide Wire, C.R. Bard, Inc. (1989) Summary page 1.

## Most influential descendants
- K023114: Lumend Frontrunner Cto Catheter (2003), 69 descendants of its own
- 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

## Indications for use
The LuMend Frontrunner™ CTO Coronary Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) prior to PTCA or stent intervention.

Source page: https://510kreport.com/device/K013284
Methodology: https://510kreport.com/methodology