Reprocessed CS Diagnostic Electrophysiology Catheter

Reprocessed CS Diagnostic Electrophysiology Catheter is an FDA 510(k)-cleared medical device (K181056) 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 January 23, 2019. Regulation: 8.