SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM

SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM is an FDA 510(k)-cleared medical device (K970099) manufactured by Nitinol Medical Technologies, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 15, 1997. Regulation: 8.