# K092175: The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200

- Pathway: 510(k) (Traditional)
- Applicant: Flowcardia, Inc.
- Decided: Feb 17, 2010 after 211 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- 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: 8 generations back to K890505 (1989). 13 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080765: Crosser LP System, Flowcardia, Inc. (2008) Summary page 1.
- K072776: The Crosser System, Flowcardia, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K230159: SoundBite® Crossing System XS Peripheral (2023), 0 descendants of its own

## Indications for use
The CROSSER S6 System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries. The CROSSER S6 Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

Source page: https://510kreport.com/device/K092175
Methodology: https://510kreport.com/methodology