The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Model 5407s, 5807s & 5410s Surg Cables.
| Device ID | K914460 |
| 510k Number | K914460 |
| Device Name: | MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | John M Otto |
| Correspondent | John M Otto MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-07 |
| Decision Date | 1991-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902035166 | K914460 | 000 |