# K093969: Acuity Break-Away Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Cardiac Pacemakers, Inc.
- Decided: Mar 5, 2010 after 72 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: 4 generations back to K953987 (1995). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031505: Rapido Cut-Away Guiding Catheter, Guidant Corporation (2003)

## Most influential descendants
- K111252: Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8F (2011), 3 descendants of its own
- K132914: Acuity Pro Lead Delivery System (2014), 2 descendants of its own
- K171612: ACUITY Pro Lead Delivery System (2017), 1 descendant of its own
- K243757: Shockwave CS Guide Catheter (2025), 0 descendants of its own

## Indications for use
The ACUITY Break-Away™ Lead Delivery System is intended to access the coronary venous system and may be used alone (8F) or in dual catheter delivery (8F with 6F). The system 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/K093969
Methodology: https://510kreport.com/methodology