REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS is an FDA 510(k)-cleared medical device (K012678) manufactured by Sterilmed, 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 August 13, 2002. Regulation: 8.