Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is an FDA 510(k)-cleared medical device (K200205) 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 May 12, 2020. Regulation: 8.