PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE

PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE is an FDA 510(k)-cleared medical device (K972201) manufactured by Sulzer Carbomedics, 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 April 13, 1998. Regulation: 8.