Device Dossier

Tubing set, irrigation pump

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

Intended purpose

The Qiona Tube Set including extension tubing is sterile flexible tubing that connects irrigating solution, the Qiona ablation irrigation pump, and the “Flux” range of cooled ablation catheters or TactiCath ablation catheters. The body of these ablation catheters has a lumen which allows the pumping of irrigation solution to the catheter tip. All tubing in the set is single use.

TGA Public Summary