MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE

MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE is an FDA 510(k)-cleared medical device (K091584) manufactured by Merit Medical Systems, 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 October 8, 2009. Regulation: 8.