PVS 1400 GUIDEWIRE

PVS 1400 GUIDEWIRE is an FDA 510(k)-cleared medical device (K990823) manufactured by Precision Vascular Systems, 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 July 22, 1999. Regulation: 8.