Cleared Traditional

D?Kutting? PTA Scoring Balloon Dilatation Catheter

K232207 · Dk Medical Technology Co., Ltd. · Cardiovascular

Mar 2024

Decision

225d

Days

Class 2

Risk

About This 510(k) Submission

K232207 is an FDA 510(k) clearance for the D?Kutting? PTA Scoring Balloon Dilatation Catheter, a Catheter, Percutaneous, Cutting/scoring (Class II — Special Controls, product code PNO), submitted by Dk Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on March 7, 2024, 225 days after receiving the submission on July 26, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K232207 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2023
Decision Date	March 07, 2024
Days to Decision	225 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