# K080154: Acuity Universal Cutter

- Pathway: 510(k) (Special)
- Applicant: Cardiac Pacemakers, Inc.
- Decided: Mar 20, 2008 after 57 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: 2 generations back to K024035 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031459: Rapido Cut-Away Cutter, Guidant Corp. (2003) Summary page 1.

## Recalls of this device
- Dec 15, 2020 · Class II · Z-0870-2021: Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.

## Indications for use
The Boston Scientific ACUITYTM Universal Cutter is intended to be used with Guidant or Boston Scientific cuttable families of guiding catheters, and is intended to facilitate guiding catheter removal after the Guidant or Boston Scientific coronary venous lead is positioned..

Source page: https://510kreport.com/device/K080154
Methodology: https://510kreport.com/methodology