Imricor Medical Systems (ASX:IMR) submitted its NavTrac and NavTrac-MR steerable introducers for market clearance under the US Food and Drug Administration's 510(k) premarket notification pathway, according to a Monday filing with the Australian bourse.
The devices are used to insert and guide a range of cardiovascular catheters into the heart during certain medical procedures, per the filing.
Imricor said it has now completed 14 of the 15 FDA submissions required to establish a full product platform in the US.
The company's shares gained 1% in recent Monday trade.
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