
Reflow Medical, Inc.
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Spur Peripheral Retrievable Stent System is an FDA 510(k)-cleared medical device (DEN240048) manufactured by Reflow 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 May 28, 2025. Regulation: 8.