# K093139: Bantam,48XXXXXX, 50XXXXXX

- Pathway: 510(k) (Special)
- Applicant: ClearStream Technologies, Ltd.
- Decided: Dec 30, 2009 after 86 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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: 2 generations back to K042537 (2004). 2 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072947: Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters, ClearStream Technologies, Ltd. (2008) Summary page 1.

## Most influential descendants
- K112335: Bantam Catheter (280MM Balloon Lengths) (2011), 5 descendants of its own
- 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
- K102035: Sleek Otw Pta Catheters (2010), 2 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/K093139
Methodology: https://510kreport.com/methodology