510(k) K061680

ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER by Atrium Medical Corp. — Product Code DQY

K061680 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER". The FDA issued a decision of Substantially Equivalent on December 15, 2006. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Atrium Medical Corp. has at least 10 other 510(k) clearances on record.