# K254212: NC PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Kossel Medtech (Suzhou) Co., Ltd.
- Decided: Sep 16, 2026 after 261 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: 7 generations back to K933483 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181323: Atlas Gold PTA Dilatation Catheter, C.R. Bard, Inc. (2018) Summary page 4.

## Indications for use
The NC PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K254212
Methodology: https://510kreport.com/methodology