GUIDER SOFTIP GUIDING CATHETER XF 5F

GUIDER SOFTIP GUIDING CATHETER XF 5F is an FDA 510(k)-cleared medical device (K010853) manufactured by Boston Scientific, Target. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 17, 2001. Regulation: 8.