# K210839: SoundBite Crossing System - Peripheral (14P)

- Pathway: 510(k) (Special)
- Applicant: Soundbite Medical Solutions, Inc.
- Decided: Apr 20, 2021 after 29 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: 10 generations back to K890505 (1989). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192211: SoundBite Console, SoundBite Active Wire 18, Soundbite Medical Solution, Inc. (2020) Summary page 5.

## Most influential descendants
- K230159: SoundBite® Crossing System XS Peripheral (2023), 0 descendants of its own

## Indications for use
SoundBite® Crossing System - Peripheral (14P) is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions. SoundBite® Crossing System - Peripheral (14P) is not intended for use in the carotid arteries.

Source page: https://510kreport.com/device/K210839
Methodology: https://510kreport.com/methodology