# K243757: Shockwave CS Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Shockwave Medical, Inc.
- Decided: May 2, 2025 after 147 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 8 generations back to K953987 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171612: ACUITY Pro Lead Delivery System, Boston Scientific Corporation (2017) Summary page 5.

## Indications for use
The Shockwave CS Guide Catheter is intended to access the coronary venous system and may be used alone (9F) or in a dual catheter delivery (e.g., 9F with 7F). The catheter serves as a conduit for the introduction of interventional/diagnostic devices introduced into the coronary venous system.

Source page: https://510kreport.com/device/K243757
Methodology: https://510kreport.com/methodology