Device Dossier

SSPC Delivery Catheter - Catheter, intravascular, guiding

Device Dossier for SSPC Delivery Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Boston Scientific).…

Intended purpose

The Delivery Catheter is indicated for the venous introduction of various types of catheters and pacing or defibrillator leads.

Functional description

The device is packaged with a dilator which aids with introduction into the vasculature. Proximally, the SSPC Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The device is designed to be slittable, thereby allowing its removal after device placement.The SSPC Delivery Catheter has an inner diameter of 6.5F, an outer diameter of 8F, and the dilator is compatible with a 0.035” guidewire.

TGA Public Summary