PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE

PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE is an FDA 510(k)-cleared medical device (K120164) manufactured by Angioslide, Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2012. Regulation: 8.