INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING

INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING is an FDA 510(k)-cleared medical device (K891580) 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 2, 1989. Regulation: 8.