The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for 6981m Lead Extender Kit, 6984m Lead Extender Kit, 6986m Lead Extender Kit, 5866-24m Lead Adaptor Kit, 5866-38m Lead Adap.
| Device ID | K132008 |
| 510k Number | K132008 |
| Device Name: | 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP |
| Classification | Pacemaker Lead Adaptor |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA STREET Mounds View, MN 55112 |
| Contact | Michele Machacek |
| Correspondent | Michele Machacek MEDTRONIC INC. 8200 CORAL SEA STREET Mounds View, MN 55112 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2013-07-30 |
| Summary: | summary |