
Sorin Group Italia S.R.L.
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XTRA is an FDA 510(k)-cleared medical device (K112245) manufactured by Sorin Group Italia S.R.L.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 5, 2011. Regulation: 8.