The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Model 6416 Transvenous Bipolar Temporary Pacing Lead.
| Device ID | K973360 |
| 510k Number | K973360 |
| Device Name: | MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVENUE, N.E. Minneapolis, MN 55432 -3576 |
| Contact | Susan Noddin |
| Correspondent | Susan Noddin MEDTRONIC VASCULAR 7000 CENTRAL AVENUE, N.E. Minneapolis, MN 55432 -3576 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-08 |
| Decision Date | 1998-05-26 |
| Summary: | summary |