SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.

SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. is an FDA 510(k)-cleared medical device (K893680) manufactured by Cathlab Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 31, 1989. Regulation: 8.