P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE

P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE is an FDA 510(k)-cleared medical device (K963989) manufactured by Cardiovascular Dynamics, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 23, 1997. Regulation: 8.