# K091119: Modification to the Crosser System

- Pathway: 510(k) (Special)
- Applicant: Flowcardia, Inc.
- Decided: May 15, 2009 after 28 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). 12 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K112308: Crosser Recanalization System (2011), 2 descendants of its own
- K161208: CROSSER CTO Recanalization Catheter (2016), 1 descendant of its own
- K101599: RVT Cto Device (2011), 1 descendant of its own
- K203363: Crosser iQ CTO Recanalization System (2021), 0 descendants of its own
- K140288: Truepath Cto Device (2014), 0 descendants of its own

## Indications for use
The CROSSER® 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® 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/K091119
Methodology: https://510kreport.com/methodology