GESCO PER-Q-CATH NEEDLE

GESCO PER-Q-CATH NEEDLE is an FDA 510(k)-cleared medical device (K911215) manufactured by Gesco Intl., Inc.. 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 5, 1991. Regulation: 8.