PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)

PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) is an FDA 510(k)-cleared medical device (K201246) manufactured by Qualimed USA, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 2021. Regulation: 8.