Device Dossier

Tubing set, irrigation pump

Device Dossier for Tubing set, irrigation pump (Tubing set, irrigation pump, Class IIa, sponsor Osstem). ARTG record, intended purpose, GMDN category —…

Intended purpose

A collection of flexible tubing, typically sterile, and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation solution to a device (e.g., an ablation catheter) at a specified flow rate during a procedure (e.g., cardiac electrophysiology ablation). The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. The contents of the set are single-use.

TGA Public Summary