Shanghai INT Medical Receives FDA Approval of INT Introducer Set for Cardiovascular Treatment

Indications for Use Statement

KDL Micro Catheter is used to provide support, to facilitate the placement of guidewires in the peripheral and coronary vasculature, and can be used to exchange one guidewire for another. It is also intended to assist in the delivery of diagnostics, embolic, or therapeutic materials into peripheral and coronary vessels.

About KDL Micro Catheter

510(k) Number:   K201706

Regulation Number:   870.1250

Classification Product Code: DQY

Date Received:  06/22/2020

Decision Date:   07/22/2021

Decision:   Substantially Equivalent (SESE)

Regulation Medical Specialty: Cardiovascular

510k Review Panel:  Cardiovascular

About INT Medical

Shanghai Kindly Medical Instruments Co., Ltd. was established in 2006, a listed company on main board of Hong Kong Exchange (KDL Medical; HK1501).

We own over 1,600 employees. The headquarter is located in Jiading, Shanghai, manufacturing cardiovascular, peripheral and neuro intervention products approved by CE and FDA (510K), with a complete industrial chain of independent mold processing, product research and development, equipment development, sterilization, etc..