STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078

STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 is an FDA 510(k)-cleared medical device (K090163) manufactured by St Jude 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 March 31, 2009. Regulation: 8.