510(k) K020634

MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER by Atrium Medical Corp. — Product Code DXE

K020634 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on May 8, 2002. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Atrium Medical Corp. has at least 10 other 510(k) clearances on record.