SOLOSTICK (AMPLATZ DILATOR NEEDLE)

SOLOSTICK (AMPLATZ DILATOR NEEDLE) is an FDA 510(k)-cleared medical device (K896096) manufactured by Microvena Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 1990. Regulation: 8.