Zurich Pressure Guidewire System Model 100

Zurich Pressure Guidewire System Model 100 is an FDA 510(k)-cleared medical device (K190852) manufactured by Zurich Medical, 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 13, 2019. Regulation: 8.