Magnetic Localization Patch Kit (AFR-00021)

Magnetic Localization Patch Kit (AFR-00021) is an FDA 510(k)-cleared medical device (K243435) manufactured by Medtronic, 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 December 4, 2024. Regulation: 8.