MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE

MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE is an FDA 510(k)-cleared medical device (K894445) manufactured by Mallinckroot, 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 October 1, 1989. Regulation: 8.