Indications for Use Statement

Y-Connector hemostasis valve is intended to minimize blood loss during the introduction, withdrawal and use of devices that have an outer diameter of 8F catheter during diagnostic and interventional procedures.

Insertion Tool facilitates introduction of a guidewire through the Y-Connector and into the guiding catheter.

Torque Device attaches to guidewires and provides a handle to assist in manipulation of the guidewire.

About Y-Connector Kit

510(k) Number:   K170024

Regulation Number:   870.4290

Classification Product Code: DTL

Date Received:  01/03/2017

Decision Date:   10/03/2017

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..