# K123765: Guidezilla Guide Extension Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Mar 19, 2013 after 102 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K120820: Giraffe Blue Spot PT Lite, Lumitex, Inc. (2012). Our reading of the summary gave K120820, FDA’s number for Giraffe Blue Spot PT Lite (Lumitex, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “GuideLiner V2 Catheter”. Kept off the family tree.

## Most influential descendants
- K163314: Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter (2017), 0 descendants of its own

## Indications for use
The Guidezilla 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/K123765
Methodology: https://510kreport.com/methodology