ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE

ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE is an FDA 510(k)-cleared medical device (K991898) manufactured by Microvena 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 June 15, 1999. Regulation: 8.