
Summit Medical Products, Inc.
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AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH is an FDA 510(k)-cleared medical device (K102460) manufactured by Summit Medical Products, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 12, 2011. Regulation: 8.