# K230159: SoundBite® Crossing System XS Peripheral

- Pathway: 510(k) (Traditional)
- Applicant: Soundbite Medical Solutions, Inc.
- Decided: Aug 28, 2023 after 221 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: 11 generations back to K890505 (1989). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210839: SoundBite Crossing System - Peripheral (14P), Soundbite Medical Solutions, Inc. (2021) Summary page 4.

## Indications for use
The SoundBite® Crossing System XS Peripheral is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions. The SoundBite® Crossing System XS Peripheral is not intended for use in the carotid arteries.

Source page: https://510kreport.com/device/K230159
Methodology: https://510kreport.com/methodology