HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH

HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH is an FDA 510(k)-cleared medical device (K101116) manufactured by Abbott Vascular-Cardiac Therapies. 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 22, 2010. Regulation: 8.