Device Dossier

Achieve Mapping Catheter Model 990063 - Catheter, cardiac, electrophysiological mapping

Device Dossier for Achieve Mapping Catheter Model 990063 - Catheter, cardiac, electrophysiological mapping (Electrophysiology cardiac catheter,…

Intended purpose

To collect intracardiac electrograms from multiple electrodes for evaluation on an electrophysiology (EP) recording system and to use for cardiac stimulation during electrophysiology studies. The mapping catheter is compatible for use with, and may be used to support and position, all catheters in the Medtronic Arctic Front family of cardiac cryoablation catheters.

Functional description

The Achieve Mapping Catheter is an intra-cardiac electrophysiology (EP) recording catheter and can be used for cardiac stimulation during electrophysiology studies.

TGA Public Summary