7 FRENCH LARGE LUMEN TRIGUIDE-PLUS

7 FRENCH LARGE LUMEN TRIGUIDE-PLUS is an FDA 510(k)-cleared medical device (K943783) manufactured by Scimed Life Systems, 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 12, 1994. Regulation: 8.