SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT

SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT is an FDA 510(k)-cleared medical device (K042445) manufactured by Bard Access Systems, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 2004. Regulation: 8.