SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER

SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER is an FDA 510(k)-cleared medical device (K092014) manufactured by Onset Medical Corporation. 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 7, 2009. Regulation: 8.