DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION

DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION is an FDA 510(k)-cleared medical device (K914985) manufactured by E-Z-Em, 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 December 19, 1991. Regulation: 8.