ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)

ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) is an FDA 510(k)-cleared medical device (K936286) manufactured by Gish Biomedical, 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 13, 1994. Regulation: 8.