AXS Infinity LS Plus Long Sheath

AXS Infinity LS Plus Long Sheath is an FDA 510(k)-cleared medical device (K193034) manufactured by Stryker Neurovascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 2019. Regulation: 8.