# K203363: Crosser iQ CTO Recanalization System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 12, 2021 after 269 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K871011 (1987). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161208: CROSSER CTO Recanalization Catheter, Bard Peripheral Vacular, Inc. (2016) Summary page 4.

## Recalls of this device
- Nov 14, 2023 · Class II · Z-0676-2024: Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indica

## Indications for use
The BD Recanalization System (console and footswitch) and Crosser iQ™ Ultrasonic CTO Device are indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. Crosser iQ™ Ultrasonic CTO Device: The Crosser iQ™ Ultrasonic CTO Device is intended for use only with the BD Recanalization System (console and footswitch). BD Recanalization System: The BD Recanalization System (console and footswitch) is intended for use only with the Crosser iQ™ Ultrasonic CTO Crossing Device.

Source page: https://510kreport.com/device/K203363
Methodology: https://510kreport.com/methodology