MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM

MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM is an FDA 510(k)-cleared medical device (K952828) 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 August 17, 1995. Regulation: 8.