Indications for Use Statement

Guidewire is intended to be used in the coronary and/or peripheral vascular system to introduce and position catheters to desired anatomical location during diagnostic or interventional procedures.

About Guidewire

510(k) Number:   K180177

Regulation Number:   870.1330

Classification Product Code: DQX

Date Received:  01/22/2018

Decision Date:   09/13/2018

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. Kindly owns more than 700 employees. The headquarter is located in Jiading, Shanghai, manufacturing cardiovascular, peripheral and neuro intervention products approved by FDA (510K), with a complete industrial chain of independent mold processing, product research and development, equipment development, sterilization, etc..