Gel-Block 10X embolization pledgets

Gel-Block 10X embolization pledgets is an FDA 510(k)-cleared medical device (K143038) manufactured by Vascular Solutions, 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 November 19, 2014. Regulation: 8.