PIOLAX HYDROPHILIC GUIDEWIRE

PIOLAX HYDROPHILIC GUIDEWIRE is an FDA 510(k)-cleared medical device (K980977) manufactured by Piolax Medical Devices, 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 26, 1998. Regulation: 8.