The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Models 5866-24m/5866-38m/5866-40m/6986m Adapt Kit.
| Device ID | K911302 |
| 510k Number | K911302 |
| Device Name: | MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT |
| Classification | Pacemaker Lead Adaptor |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Jennifer M Marrone |
| Correspondent | Jennifer M Marrone 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 | 1991-03-25 |
| Decision Date | 1991-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490153713 | K911302 | 000 |
| 00681490136952 | K911302 | 000 |
| 00681490136907 | K911302 | 000 |
| 00681490136785 | K911302 | 000 |