SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION

SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION is an FDA 510(k)-cleared medical device (K935022) 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 January 17, 1994. Regulation: 8.