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Pathway Medical Technologies, Inc.
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JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 is an FDA 510(k)-cleared medical device (K082664) manufactured by Pathway Medical Technologies, 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 October 5, 2008. Regulation: 8.