PULMOCATH INTRABRONCHIAL CATHETER

PULMOCATH INTRABRONCHIAL CATHETER is an FDA 510(k)-cleared medical device (K901615) manufactured by Omnitron Intl., Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 26, 1992. Regulation: 8.