Device Dossier

Pleural/peritoneal cavity drain-insertion set

Device Dossier for Pleural/peritoneal cavity drain-insertion set (Pleural/peritoneal cavity drain-insertion set, Class IIb, sponsor Becton Dickinson).…

Intended purpose

A prepackaged kit/tray containing sterile devices intended for catheterisation of the pleural/peritoneal cavity for intermittent, long-term drainage and/or aspiration of effusions, ascites, and/or air, for the palliation of symptoms (e.g. dyspnea due to pleural effusion, or recurrent ascites). It includes an implantable pleural/peritoneal catheter and number of accessories to aid in its implantation including, but not limited to, a J-Tip guidewire, tunnelers, foam pad, introducer needle.

TGA Public Summary