# K160941: Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Brosmed Medical Co., Ltd.
- Decided: Dec 13, 2016 after 253 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 27 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.

## Recalls of this device
- Dec 14, 2018 · Class II · Z-0963-2019: Incorrect (higher) Rated Burst Pressure information printed on label.

## 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/K160941
Methodology: https://510kreport.com/methodology