CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.

CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. is an FDA 510(k)-cleared medical device (K863917) manufactured by Cardio-Vascular Innovations, 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 January 5, 1987. Regulation: 8.