# K151153: Pirouette 018

- Pathway: 510(k) (Traditional)
- Applicant: Arravasc Limited
- Decided: Aug 20, 2015 after 112 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: 9 generations back to K001134 (2000). 30 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112335: Bantam Catheter (280MM Balloon Lengths), ClearStream Technologies, Ltd. (2011) Summary page 4.
- K093139: Bantam,48XXXXXX, 50XXXXXX, ClearStream Technologies, Ltd. (2009) Summary page 4.
- K133843: Saber Percutaneous Transluminal Angioplasty Dilatation Catheter, Cordis Corporation (2014) Summary page 4.

## Most influential descendants
- 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
Pirouette 018 is intended for balloon dilation of the iliac, femoral, popliteal, infra-popliteal and renal arteries.

Source page: https://510kreport.com/device/K151153
Methodology: https://510kreport.com/methodology