The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 5857-3m Lead End Cap Kit.
| Device ID | K911048 |
| 510k Number | K911048 |
| Device Name: | MODEL 5857-3M LEAD END CAP 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 | 1991-03-08 |
| Decision Date | 1991-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994500298 | K911048 | 000 |
| 00763000059460 | K911048 | 000 |