MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F

MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F is an FDA 510(k)-cleared medical device (K050558) manufactured by C.R. Bard, 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 August 28, 2005. Regulation: 8.