Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

AngioDynamics, Inc.
Free shipping on orders over $99 · 30-day returns
MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K062609) manufactured by AngioDynamics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 5, 2006. Regulation: 8.