NEW HYDROPHILIC COATING FOR WIRE GUIDES

NEW HYDROPHILIC COATING FOR WIRE GUIDES is an FDA 510(k)-cleared medical device (K924385) manufactured by Arrow Intl., 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 August 14, 1993. Regulation: 8.