SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH

SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH is an FDA 510(k)-cleared medical device (K940545) 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 May 5, 1994. Regulation: 8.