The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Model 5318 Temporary Pacemaker/implant Tool.
| Device ID | K971474 |
| 510k Number | K971474 |
| Device Name: | MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
| Contact | Lorna J Harmuth |
| Correspondent | Lorna J Harmuth MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-23 |
| Decision Date | 1997-07-14 |
| Summary: | summary |