Polaris X™ Unidirectional Steerable Diagnostic Catheter

Polaris X™ Unidirectional Steerable Diagnostic Catheter is an FDA 510(k)-cleared medical device (K233207) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2023. Regulation: 8.