RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI

RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI is an FDA 510(k)-cleared medical device (K840336) manufactured by Arrow Intl., 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 February 16, 1984. Regulation: 8.