Clearance Summary
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP received FDA 510(k) clearance under submission number K132008, sponsored by Medtronic, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-07-30.
- Submission: K132008
- Applicant / Sponsor: Medtronic, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3620
- Decision date: 2013-07-30
Classification & Regulation
This clearance is catalogued under FDA product code DTD and 21 CFR 870.3620, within the Cardiovascular review panel as a Class II device.