DILATOR, VESSEL & INTRODUCER, SHEATH

DILATOR, VESSEL & INTRODUCER, SHEATH is an FDA 510(k)-cleared medical device (K780126) manufactured by Argon Medical 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 March 1, 1978. Regulation: 8.