DETACHABLE SILICONE BALLOON (DSB)

DETACHABLE SILICONE BALLOON (DSB) is an FDA 510(k)-cleared medical device (K964488) manufactured by Target Therapeutics. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 1998. Regulation: 8.