# K161427: Pirouette 035

- Pathway: 510(k) (Special)
- Applicant: Arravasc Limited
- Decided: Jul 30, 2016 after 68 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: 10 generations back to K001134 (2000). 31 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151153: Pirouette 018, Arravasc Limited (2015) Summary page 4.

## Most influential descendants
- K173621: Advocate PTA Catheter (2017), 1 descendant of its own
- K192907: Advocate PTA Catheter (2019), 0 descendants of its own

## Indications for use
Piroutte 035 PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, infra-popliteal and renal arteries.

Source page: https://510kreport.com/device/K161427
Methodology: https://510kreport.com/methodology