REPROCESSED ELECTROPHYSIOLOGY CATHETERS

REPROCESSED ELECTROPHYSIOLOGY CATHETERS is an FDA 510(k)-cleared medical device (K112232) manufactured by Stryker Sustainability Solutions. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 2011. Regulation: 8.