BioCardia announces FDA market clearance of Morph DNA Steerable Introducer

BioCardia announced that the Food and Drug Administration, FDA, has cleared BioCardia to market the Morph DNA Steerable Introducer product family, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act. The patented Morph DNA Steerable Introducer product family now has FDA market clearance to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart. The clearance covers sixteen products in lengths of 30, 45, 71, and 90 centimeters in 5, 6, 7, and 8 French introducer sheath equivalent diameters.