510(k) K050814

ATRIUM ICAST COVERED STENT by Atrium Medical Corp. — Product Code JCT

K050814 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "ATRIUM ICAST COVERED STENT". The FDA issued a decision of Substantially Equivalent on May 6, 2005. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Atrium Medical Corp. has at least 10 other 510(k) clearances on record.