LAGUNA SOFTIP DIAGNOSTIC CATHETERS

LAGUNA SOFTIP DIAGNOSTIC CATHETERS is an FDA 510(k)-cleared medical device (K961499) manufactured by Boston Scientific Scimed, 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 October 16, 1996. Regulation: 8.