PCI W/CATH-SEAL SIDE FLOW FITTING

PCI W/CATH-SEAL SIDE FLOW FITTING is an FDA 510(k)-cleared medical device (K842259) manufactured by Universal Medical Instrument 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 July 31, 1984. Regulation: 8.