# K163314: Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Mar 23, 2017 after 120 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 K123765 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123765: Guidezilla Guide Extension Catheter, Boston Scientific (2013) Summary page 4.

## Recalls of this device
- Oct 24, 2019 · Class II · Z-0578-2020: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufact

## Indications for use
The Guidezilla IT Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

Source page: https://510kreport.com/device/K163314
Methodology: https://510kreport.com/methodology