MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX

MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX is an FDA 510(k)-cleared medical device (K101784) manufactured by Great Batch Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 2010. Regulation: 8.