BLAZER DX-20 DIAGNOSTIC CATHETER

BLAZER DX-20 DIAGNOSTIC CATHETER is an FDA 510(k)-cleared medical device (K081576) 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 February 2, 2009. Regulation: 8.