510(k) K982187

FAST-CATH INTRA-CARDIAC INTRODUCER by Daig Corp. — Product Code DYB

K982187 is an FDA 510(k) premarket notification submitted by Daig Corp. for the device "FAST-CATH INTRA-CARDIAC INTRODUCER". The FDA issued a decision of Substantially Equivalent on September 16, 1998. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Daig Corp. has at least 10 other 510(k) clearances on record.