# K111252: Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8F

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jun 2, 2011 after 30 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: 5 generations back to K953987 (1995). 8 ancestors in all.
3 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.
- K031459: Rapido Cut-Away Cutter, Guidant Corp. (2003) Summary page 1.

## Most influential descendants
- 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 TM Cut-Away~m Lead Delivery System is intended to access the coronary venous system and may be used alone (8F or 6F) or in a dual catheter delivery (8F and 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/K111252
Methodology: https://510kreport.com/methodology