Sphere-9Dx Diagnostic Catheter (AFR-00009)

Sphere-9Dx Diagnostic Catheter (AFR-00009) is an FDA 510(k)-cleared medical device (K233433) manufactured by Medtronic. 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 6, 2024. Regulation: 8.