# K080765: Crosser LP System

- Pathway: 510(k) (Traditional)
- Applicant: Flowcardia, Inc.
- Decided: Jun 20, 2008 after 94 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K890505 (1989). 11 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062868: The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02, Flowcardia, Inc. (2007) Summary page 1.

## Most influential descendants
- K092175: The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200 (2010), 6 descendants of its own
- K192211: SoundBite Console, SoundBite Active Wire 18 (2020), 2 descendants of its own
- K112308: Crosser Recanalization System (2011), 2 descendants of its own
- K210839: SoundBite Crossing System - Peripheral (14P) (2021), 1 descendant of its own
- K161208: CROSSER CTO Recanalization Catheter (2016), 1 descendant of its own

## Indications for use
The CROSSER LP 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/K080765
Methodology: https://510kreport.com/methodology