# K121839: Unballoon Non-Occlusive Modeling Catheter

- Pathway: 510(k) (Special)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Aug 8, 2012 after 47 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: 4 generations back to K003495 (2001). 7 ancestors in all.
2 later devices descend from it; 2 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)
- K110891: The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling Catheter, LeMaitre Vascular, Inc. (2011)

## Most influential descendants
- 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/K121839
Methodology: https://510kreport.com/methodology