SCIMED EN TRE' III PTCA GUIDE WIRE

SCIMED EN TRE' III PTCA GUIDE WIRE is an FDA 510(k)-cleared medical device (K942333) 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 August 30, 1994. Regulation: 8.