Cleared Traditional

D?Kutting? LL Peripheral Scoring Balloon Dilatation Catheter

K242254 · Dk Medical Technology Co., Ltd. · Cardiovascular

Apr 2025

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K242254 is an FDA 510(k) clearance for the D?Kutting? LL Peripheral Scoring Balloon Dilatation Catheter, a Catheter, Percutaneous, Cutting/scoring (Class II — Special Controls, product code PNO), submitted by Dk Medical Technology Co., Ltd. (Jiangsu, CN). The FDA issued a Cleared decision on April 21, 2025, 264 days after receiving the submission on July 31, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K242254 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2024
Decision Date	April 21, 2025
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PNO — Catheter, Percutaneous, Cutting/scoring
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material