EXTRACORP.'S INTERSEPT CUS. TUBING PK.

EXTRACORP.'S INTERSEPT CUS. TUBING PK. is an FDA 510(k)-cleared medical device (K800178) manufactured by Extracorporeal Medical Specialities, 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 February 20, 1980. Regulation: 8.