PVS 2000 SYNCHRO2 GUIDEWIRE

PVS 2000 SYNCHRO2 GUIDEWIRE is an FDA 510(k)-cleared medical device (K053268) manufactured by Boston Scientific - Precision Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 2006. Regulation: 8.