# K171612: ACUITY Pro Lead Delivery System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jun 30, 2017 after 29 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: 7 generations back to K953987 (1995). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132914: Acuity Pro Lead Delivery System, Boston Scientific (2014) Summary page 5.

## Most influential descendants
- K243757: Shockwave CS Guide Catheter (2025), 0 descendants of its own

## Indications for use
The ACUITY™ Pro Lead Delivery System is intended to access the coronary venous system, and may be used alone (9F) or in a dual catheter delivery (9F with 7F). The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.

Source page: https://510kreport.com/device/K171612
Methodology: https://510kreport.com/methodology