
Lake Region Mfg., Inc.
Free shipping on orders over $99 · 30-day returns
HYDROPHILIC COATED GUIDEWIRE is an FDA 510(k)-cleared medical device (K981667) manufactured by Lake Region Mfg., Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 4, 1998. Regulation: 8.