
Hotspur Technologies
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PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM is an FDA 510(k)-cleared medical device (K100842) manufactured by Hotspur Technologies. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 11, 2010. Regulation: 8.