CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM

CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM is an FDA 510(k)-cleared medical device (K965140) manufactured by Cardio Metrics, 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 17, 1997. Regulation: 8.