The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 6984m Lead Extender Kit.
| Device ID | K915724 |
| 510k Number | K915724 |
| Device Name: | MODEL 6984M LEAD EXTENDER KIT |
| Classification | Pacemaker Lead Adaptor |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Tracy Malm |
| Correspondent | Tracy Malm MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-20 |
| Decision Date | 1992-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490153621 | K915724 | 000 |