# K033670: Gore Tri-Lobe Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 5, 2004 after 163 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: 1 generation back to K003495 (2001). 3 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003495: Ancure Lliac Balloon Catheter, Guidant Cardiac and Vascular Surgery (2001) Summary page 2.
- K021721: Equalizer Balloon Catheter, Boston Scientific Corp (2002) Summary page 2.
- K002286: Ldob Occlusion Balloon Catheter, Cook, Inc. (2001) Summary page 2.

## Most influential descendants
- K110891: The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling Catheter (2011), 3 descendants of its own
- K121839: Unballoon Non-Occlusive Modeling Catheter (2012), 2 descendants of its own
- K081799: Gore Tri-Lobe Balloon Catheter (2008), 2 descendants of its own
- K123531: Unballoon Non-Occlusive Modeling Catheter (2012), 1 descendant of its own
- K243184: SAT CenterFlow Molding Balloon Catheter (IN20-00313) (2025), 0 descendants of its own

## Indications for use
The Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

Source page: https://510kreport.com/device/K033670
Methodology: https://510kreport.com/methodology