
Neocoil, LLC
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1.5T 16CH FLEX SPEEDER LARGE is an FDA 510(k)-cleared medical device (K121362) manufactured by Neocoil, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 14, 2012. Regulation: 8.