The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 6491 Unipolar Pediatric Temporary Pacing Lead.
| Device ID | K012454 |
| 510k Number | K012454 |
| Device Name: | MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis, MN 55432 -3576 |
| Contact | Tina Benoit |
| Correspondent | Tina Benoit MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis, MN 55432 -3576 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-01 |
| Decision Date | 2001-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994365419 | K012454 | 000 |