# K160256: Polux , Minerva and Atropos PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Brosmed Medical Co., Ltd.
- Decided: Jul 29, 2016 after 179 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: 11 generations back to K001134 (2000). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141118: Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter, Ev3, Inc. (2014) Summary page 4.
- K132430: Sterling Over-the-Wire (Otw) Pta Balloon Dilatation Catheter, Boston Scientific Corp (2013) Summary page 4.
- K103751: Mustang Balloon Dilatation Catheters, Boston Scientific (2011) Summary page 4.

## Most influential descendants
- K243704: Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter (2025), 0 descendants of its own

## Indications for use
The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

Source page: https://510kreport.com/device/K160256
Methodology: https://510kreport.com/methodology