The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Models 5455l And 5455sl Surgical Cables.
| Device ID | K923407 |
| 510k Number | K923407 |
| Device Name: | MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES |
| Classification | Electrode, Pacemaker, Temporary |
| 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 | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-10 |
| Decision Date | 1992-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10681490136362 | K923407 | 000 |
| 10681490136355 | K923407 | 000 |