(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000

(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 is an FDA 510(k)-cleared medical device (K901253) manufactured by Bio Medicus, 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 September 4, 1990. Regulation: 8.