# K242254: D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Dk Medical Technology Co., Ltd.
- Decided: Apr 21, 2025 after 264 days
- Product code: PNO (Catheter, Percutaneous, Cutting/Scoring)
- 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 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)
- K103459: Vascutrak Pta Dilatation Catheter, C.R. Bard, Inc. (2010) Summary page 5.

## Indications for use
The D-KuttingTm LL Peripheral Scoring Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in the coronary vasculature.

Source page: https://510kreport.com/device/K242254
Methodology: https://510kreport.com/methodology