Indications for Use Statement

Inflation Device is intended to be used in PTCA or PTA procedures to create and monitor pressure in the balloon and to deflate the balloon dilatation catheter.

About Inflation Device

510(k) Number:   K170027

Regulation Number:   870.1650

Classification Product Code: MAV

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..