# K243704: Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Brosmed Medical Co., Ltd.
- Decided: Feb 27, 2025 after 90 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: 12 generations back to K001134 (2000). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160256: Polux , Minerva and Atropos PTA Balloon Dilatation Catheter, Brosmed Medical Co., Ltd. (2016) Summary page 5.

## Indications for use
The Parafleet SC 014 / Parafleet SC 018 / Parafleet SC 035 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/K243704
Methodology: https://510kreport.com/methodology