SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER

SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER is an FDA 510(k)-cleared medical device (K931479) manufactured by Mallinckrodt 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 October 5, 1993. Regulation: 8.