Achieve ST Mapping Catheter, Catheter Connecting Cable

Achieve ST Mapping Catheter, Catheter Connecting Cable is an FDA 510(k)-cleared medical device (K153139) 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 May 5, 2016. Regulation: 8.