KAYAK HYDROPHILIC GUIDE WIRES

KAYAK HYDROPHILIC GUIDE WIRES is an FDA 510(k)-cleared medical device (K014195) manufactured by Boston Scientific Corp. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 18, 2002. Regulation: 8.