JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300

JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 is an FDA 510(k)-cleared medical device (K083489) manufactured by Pathway Medical Technologies, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 22, 2009. Regulation: 8.