510(k) K153554

Genesis Low Temperature Reusable Rigid Container System by Carefusion 2200, Inc. — Product Code KCT

K153554 is an FDA 510(k) premarket notification submitted by Carefusion 2200, Inc. for the device "Genesis Low Temperature Reusable Rigid Container System". The FDA issued a decision of Substantially Equivalent on March 21, 2016. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Carefusion 2200, Inc. has at least 10 other 510(k) clearances on record.