PTFE PEEL AWAY MICROINTRODUCER

PTFE PEEL AWAY MICROINTRODUCER is an FDA 510(k)-cleared medical device (K072130) manufactured by Intromed. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 2007. Regulation: 8.