
Spectranetics Corp.
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CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 is an FDA 510(k)-cleared medical device (K052514) manufactured by Spectranetics Corp.. 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 18, 2005. Regulation: 8.