FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)

FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) is an FDA 510(k)-cleared medical device (K051519) manufactured by Abbott Laboratories (Perclose, 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 June 20, 2005. Regulation: 8.