
Angioslide, Ltd.
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EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE is an FDA 510(k)-cleared medical device (K090364) 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 March 22, 2010. Regulation: 8.