# K031459: Rapido Cut-Away Cutter

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Jul 23, 2003 after 76 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: 1 generation back to K024035 (2002). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024035: Attain 6218A-AM Amplatz Guide Catheter for Left-Heart Delivery, Medtronic Vascular (2002) Summary page 1.

## 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
- K080154: Acuity Universal Cutter (2008), 0 descendants of its own

## Recalls of this device
- Jan 7, 2011 · Not classified · Z-2793-2011: Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validat

## Indications for use
The RAPIDO™ Cut-Away™ Cutter is intended to facilitate RAPIDO™ Cut-Away™ Guiding Catheter removal after the Guidant coronary venous lead is positioned.

Source page: https://510kreport.com/device/K031459
Methodology: https://510kreport.com/methodology