STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012

STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 is an FDA 510(k)-cleared medical device (K083727) manufactured by Bridgepoint Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 19, 2009. Regulation: 8.