TEFLON COATED GUIDE WIRES & CATHETER

TEFLON COATED GUIDE WIRES & CATHETER is an FDA 510(k)-cleared medical device (K822586) manufactured by Universal Medical Instrument Corp.. 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 17, 1982. Regulation: 8.