DK Score Coronary Scoring Balloon Dilatation Catheter

Primary DI

06923533800852

Basic UDI-DI Code

69722536014CSL5K

Reference

CSL-2515

Device Types

Single use Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

DK Medical Technology Co., Ltd.

The coronary scoring balloon dilation catheter packaged as sterile and intended for single use in a radiology suite/catheterization laboratory/operating room in conjunction with radiologic equipment for fluoroscopic imaging. The product is a rapid exchange catheter, which is made of Pebax and nylon material with a PTFE jacket covering the stainless steel hypo-tube. The device consists of a catheter with a non-compliant balloon attached at the distal tip. 3 scoring wires are attached on the surface of the balloon. The product is indicated for dilatation of intravascular stenotic lesions during coronary angioplasty.

The Basic UDI-DI associated with this device has 16 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDR).