# K112335: Bantam Catheter (280MM Balloon Lengths)

- Pathway: 510(k) (Traditional)
- Applicant: ClearStream Technologies, Ltd.
- Decided: Oct 12, 2011 after 61 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 K042537 (2004). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093139: Bantam,48XXXXXX, 50XXXXXX, ClearStream Technologies, Ltd. (2009) Summary page 2.

## Most influential descendants
- K151153: Pirouette 018 (2015), 4 descendants of its own
- K162316: Pirouette 014 (2016), 2 descendants of its own
- K161427: Pirouette 035 (2016), 2 descendants of its own
- K173621: Advocate PTA Catheter (2017), 1 descendant of its own
- K192907: Advocate PTA Catheter (2019), 0 descendants of its own

## Indications for use
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

Source page: https://510kreport.com/device/K112335
Methodology: https://510kreport.com/methodology