MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM

MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM is an FDA 510(k)-cleared medical device (K891121) manufactured by Boston Scientific Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 1989. Regulation: 8.