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…
- GMDN category: Catheter, intravascular, guiding
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