# K112308: Crosser Recanalization System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 17, 2011 after 6 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: 17 generations back to K871011 (1987). 63 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 66 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.
- K091119: Modification to the Crosser System, Flowcardia, Inc. (2009) Summary page 1.
- K092175: The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200, Flowcardia, Inc. (2010) Summary page 1.
- K090521: Diamondback 360 DBX, Cardiovascular Systems, Inc. (2009) Summary page 1.
- K110626: Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L System, Pathway Medical Technologies, Inc. (2011) Summary page 1.

## Most influential descendants
- K161208: CROSSER CTO Recanalization Catheter (2016), 1 descendant of its own
- K203363: Crosser iQ CTO Recanalization System (2021), 0 descendants of its own

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

Source page: https://510kreport.com/device/K112308
Methodology: https://510kreport.com/methodology