GORE TIPS Set -TSET1016 - Portosystemic needle set

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

W L Gore & Associates (Australia) Pty Ltd

Class:

Class III

Manufactured by:

WL Gore & Associates Inc 1505 North Fourth Street, Flagstaff, AZ, 86004 United States Of America

Therapeutic area:

62455 - Portosystemic needle set

Therapeutic indications:

The GORE TIPS Set consists of the GORE? TIPS Sheath and the GORE TIPS Needle. The GORE? TIPS Sheath consists of a flexible introducer sheath with a hemostatic valve and a dilator. The introducer sheath includes an inner PTFE layer, a stainless steel coil and an outer jacket. The GORE TIPS Needle consists of a stainless steel hollow shaft and a guiding catheter. The needle handle has a direction indicator to allow identification of the leading end curvature direction. The device is intended to be used as a Transjugular Intrahepatic Portosystemic Shunt access set, or TIPS Set.

Authorization status:

A

Authorization date:

2023-08-17