Reprocessed Electrophysiology Diagnostic Catheters

Reprocessed Electrophysiology Diagnostic Catheters is an FDA 510(k)-cleared medical device (K150357) 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 26, 2015. Regulation: 8.