
Vascular Solutions, Inc.
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GEL-BLOCK EMBOLIZATION PLEDGETS is an FDA 510(k)-cleared medical device (K113266) 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 May 13, 2012. Regulation: 8.