OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER

OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER is an FDA 510(k)-cleared medical device (K093232) manufactured by Great Batch Medical. 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 14, 2010. Regulation: 8.