Medtronic Stedi Extra Support Guidewire

Medtronic Stedi Extra Support Guidewire is an FDA 510(k)-cleared medical device (K250075) 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 June 12, 2025. Regulation: 8.