# K172033: Pirouette High Pressure (HP)

- Pathway: 510(k) (Traditional)
- Applicant: Arravasc, Ltd.
- Decided: Aug 31, 2017 after 57 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: 6 generations back to K001134 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103751: Mustang Balloon Dilatation Catheters, Boston Scientific (2011) Summary page 4.

## Indications for use
Pirouette High Pressure (HP) PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, infrapopliteal, renal arteries, Arterio-venous Fistula (AVF) and Arterio-venous Graft (AVG).

Source page: https://510kreport.com/device/K172033
Methodology: https://510kreport.com/methodology