510(k) K132008

6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP by Medtronic, Inc. — Product Code DTD

K132008 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP". The FDA issued a decision of Substantially Equivalent on July 30, 2013. The device falls under product code DTD (Pacemaker Lead Adaptor), a Class II device regulated under 21 CFR 870.3620. Medtronic, Inc. has at least 10 other 510(k) clearances on record.