# K062868: The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02

- Pathway: 510(k) (Traditional)
- Applicant: Flowcardia, Inc.
- Decided: Jan 19, 2007 after 116 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: 6 generations back to K890505 (1989). 10 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032031: Safe-Cross Radio Frequency Total Occlusion Crossing System, Intra Luminal Therapeutics, Inc. (2004) Summary page 1.

## Most influential descendants
- K072776: The Crosser System (2007), 28 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
- K140185: Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console (2014), 7 descendants of its own

## Indications for use
The CROSSER System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.

Source page: https://510kreport.com/device/K062868
Methodology: https://510kreport.com/methodology
