SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA

SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA is an FDA 510(k)-cleared medical device (K923480) 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 5, 1992. Regulation: 8.