MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS

MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS is an FDA 510(k)-cleared medical device (K883755) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on November 16, 1988. Regulation: 8.