
Lake Region Mfg., Inc.
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CORE AND COIL ASSEMBLY GUIDEWIRE is an FDA 510(k)-cleared medical device (K970994) manufactured by Lake Region Mfg., Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 24, 1997. Regulation: 8.