ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F

ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F is an FDA 510(k)-cleared medical device (K111252) 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 June 1, 2011. Regulation: 8.