# K023223: Modification to Lumend Frontrunner Cto Catheter

- Pathway: 510(k) (Special)
- Applicant: Lumend, Inc.
- Decided: Oct 24, 2002 after 27 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
No predicates in its family tree.
33 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K132841: Zyno Medical Administration Set, Zyno Medical, LLC (2014). Our reading of the summary gave K132841, which FDA decided on Jan 23, 2014, after this device was decided (Oct 24, 2002), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1.

## Most influential descendants
- 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
- 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

## 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/K023223
Methodology: https://510kreport.com/methodology