Device Dossier

Occlutech Delivery Set III - Catheter, intravascular, guiding

Device Dossier for Occlutech Delivery Set III - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Life Systems…

Intended purpose

The Delivery Set is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other placements.

Functional description

The Delivery Set consists of a braided sheath with a side port with a three-way stopcock, hemostatic valve, dilator and loader. The distal tip of the sheath is radiopaque and contains side flush portholes. The dilator can be locked on to the hub of the sheath.Contents of Package: 1. Delivery Sheath, 2. Dilator, 3. Loader, 4. IFU

TGA Public Summary