TEFLON COATED GUIDEWIRE

TEFLON COATED GUIDEWIRE is an FDA 510(k)-cleared medical device (K902153) manufactured by Guidewire Technologies, 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 July 30, 1990. Regulation: 8.