
Medtronic Vascular
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GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 is an FDA 510(k)-cleared medical device (K091582) manufactured by Medtronic 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 December 3, 2009. Regulation: 8.