# K011562: Lumend Percutaneous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Lumend, Inc.
- Decided: Jan 16, 2002 after 240 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: 1 generation back to K000677 (2000). 3 ancestors in all.
105 later devices descend from it; 3 cite it directly.
1 of 109 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001992: Ilt 0.014 Catheter, Model C114NL2, Intra Luminal Therapeutics, Inc. (2000) Summary page 1.
- K000677: Zuma Guide Catheters, Medtronic Vascular (2000) Summary page 1.
- K001435: Viking Optima Guiding Catheter, Guidant Corp. (2000) Summary page 1.

## Most influential descendants
- K052258: Vascular Solutions Skyway Support Catheter (2005), 80 descendants of its own
- K070372: Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610 (2007), 44 descendants of its own
- K082337: Minnie Support Catheter (2009), 35 descendants of its own
- K080987: Bridgepoint Medical Stingray Device and Accessories (2009), 24 descendants of its own
- K083313: Wildcat 7F Guidewire Support Catheter (2009), 21 descendants of its own

## Indications for use
The LuMend Percutaneous Catheter is intended to be used in conjunction with a steerable guide wire in order to access discreet regions of the coronary vasculature. It may be used to facilitate placement of guide wires and other interventional devices.

Source page: https://510kreport.com/device/K011562
Methodology: https://510kreport.com/methodology