# K161208: CROSSER CTO Recanalization Catheter

- Pathway: 510(k) (Special)
- Applicant: Bard Peripheral Vacular, Inc.
- Decided: May 24, 2016 after 26 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: 18 generations back to K871011 (1987). 64 ancestors in all.
1 later device descends 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)
- K112308: Crosser Recanalization System, C.R. Bard, Inc. (2011) Summary page 4.

## Most influential descendants
- K203363: Crosser iQ CTO Recanalization System (2021), 0 descendants of its own

## Indications for use
The CROSSER CTO Recanalization System indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. The CROSSER CTO 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/K161208
Methodology: https://510kreport.com/methodology