510(k) K003454

A1-CS-SB Y-ADAPTER, MODEL 124 871 by Biotronik, Inc. — Product Code DTD

K003454 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "A1-CS-SB Y-ADAPTER, MODEL 124 871". The FDA issued a decision of ST on January 18, 2001. The device falls under product code DTD (Pacemaker Lead Adaptor), a Class II device regulated under 21 CFR 870.3620. Biotronik, Inc. has at least 10 other 510(k) clearances on record.