# K110891: The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling Catheter

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Sep 13, 2011 after 167 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: 3 generations back to K003495 (2001). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032869: Cook Coda Balloon Catheter, Cook, Inc. (2003) Summary page 1.
- K050038: Reliant Stent Graft Balloon Catheter, Medtronic Endovascular Innovations (2005) Summary page 1.
- K033670: Gore Tri-Lobe Balloon Catheter, W. L. Gore & Associates, Inc. (2004) Summary page 1.

## Most influential descendants
- K121839: Unballoon Non-Occlusive Modeling Catheter (2012), 2 descendants of its own
- K123531: Unballoon Non-Occlusive Modeling Catheter (2012), 1 descendant of its own
- K133026: Unballoon Non-Occlusion Modeling Catheter (2013), 0 descendants of its own

## Indications for use
The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.

Source page: https://510kreport.com/device/K110891
Methodology: https://510kreport.com/methodology