Shanghai Kindly Medical Receives FDA Approval of High Pressure Tubing for Supporting Cardiovascular Treatment

Indications for Use Statement

High Pressure Tubing is indicated for use as a connecting line fore injection of contrast media or saline during coronary angiographic procedure.

About High Pressure Tubing

510(k) Number:   K170014

Regulation Number:   870.1650

Classification Product Code: DXT

Date Received:  01/03/2017

Decision Date:   10/06/2017

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 600 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..