BioCardia Announces 510(k) for Applications Using Morph Guide

BioCardia announced the approval of its 510(k) application by the FDA for using its Morph Universal Deflectable Guide Catheter in peripheral cardiovascular surgical applications. The indications for use deem that the Morph is intended to provide a pathway through which medical instruments such as balloon dilation catheters, guide wires or other therapeutic devices may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

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