AV Medical Technologies said today it won expanded FDA 510(k) clearance for its Chameleon PTA balloon catheter designed for the infusion of diagnostic or therapeutic fluids. The Chameleon is designed to allow operators to inject diagnostic or therapeutic fluids through the catheter during procedures, whether the balloon is inflated or deflated and while maintaining wire […]
AV Medical
AV Medical wins FDA 510(k) for Chameleon balloon catheter
Israel based AV Medical said today it won FDA 510(k) clearance for its Chameleon angioplasty balloon catheter. The company’s Chameleon catheter comes equipped with proximal injection port technology which the company claims make it the 1st and only angioplasty balloon catheter that allows for simultaneous balloon inflation and injection of intravascular fluids during guidewire access. […]