PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG

PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG is an FDA 510(k)-cleared medical device (K902057) manufactured by Datascope 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 September 24, 1990. Regulation: 8.