
Foxhollow Technologies, Inc.
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MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 is an FDA 510(k)-cleared medical device (K061063) manufactured by Foxhollow 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 May 17, 2006. Regulation: 8.