# K132914: Acuity Pro Lead Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Apr 3, 2014 after 198 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 6 generations back to K953987 (1995). 9 ancestors in all.
2 later devices descend 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)
- K093969: Acuity Break-Away Guide Catheter, Cardiac Pacemakers, Inc. (2010) Summary page 1.
- K111252: Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8F, Boston Scientific Corp (2011) Summary page 1.

## Most influential descendants
- K171612: ACUITY Pro Lead Delivery System (2017), 1 descendant of its own
- K243757: Shockwave CS Guide Catheter (2025), 0 descendants of its own

## Recalls of this device
- Nov 25, 2015 · Class II · Z-0588-2016: Potential for separation of the proximal handle from the shaft.

## 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/K132914
Methodology: https://510kreport.com/methodology