510(k) K945413

MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT by Medtronic Vascular — Product Code MAJ

K945413 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT". The FDA issued a decision of Substantially Equivalent on May 24, 1995. The device falls under product code MAJ (Catheter, Percutaneous, Intraspinal, Short Term), a Class II device regulated under 21 CFR 868.5120. Medtronic Vascular has at least 10 other 510(k) clearances on record.