
Neocoil, LLC
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1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM is an FDA 510(k)-cleared medical device (K123272) 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 March 27, 2013. Regulation: 8.