Device Dossier

SSPC NXT Delivery Catheter - Catheter, intravascular, guiding

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

Intended purpose

The Delivery Catheter is intended for the venous introduction of pacing or defibrillation leads.

Functional description

The device is packaged with a dilator which aids with introduction into the vasculature. Proximally, the SSPC NXT 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 NXT Delivery Catheter has an inner diameter of 7F, an outer diameter of 9F, and the dilator is compatible with a 0.035” guidewire.

TGA Public Summary