GRAFTGUARD PRESSURE CONTROLLING SYRINGE

GRAFTGUARD PRESSURE CONTROLLING SYRINGE is an FDA 510(k)-cleared medical device (K082725) manufactured by Maquet Cardiovascular, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 16, 2008. Regulation: 8.