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

Indications for Use Statement

Femoral Artery Introducer Set is intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into the femoral artery while minimizing blood loss during interventional procedures.

Radial Artery Introducer Set is intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.

About INT Introducer Set

510(k) Number:   K222647

Regulation Number:   870.1340

Classification Product Code: DYB  

Date Received:  09/01/2022

Decision Date:   09/13/2022

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).

Shanghai Kindly owns 14 subsidiaries with 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..