The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Paceart System.
| Device ID | K024278 |
| 510k Number | K024278 |
| Device Name: | PACEART SYSTEM |
| Classification | Electrocardiograph |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Karen Ruth-jarmon |
| Correspondent | Karen Ruth-jarmon MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | DPS |
| Subsequent Product Code | DXH |
| Subsequent Product Code | KRE |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-23 |
| Decision Date | 2003-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994845801 | K024278 | 000 |
| 00643169357730 | K024278 | 000 |
| 00613994371751 | K024278 | 000 |
| 00613994533241 | K024278 | 000 |
| 00613994533265 | K024278 | 000 |
| 00613994533272 | K024278 | 000 |
| 00613994533296 | K024278 | 000 |
| 00613994533302 | K024278 | 000 |
| 00613994533319 | K024278 | 000 |
| 00613994533333 | K024278 | 000 |
| 00613994533340 | K024278 | 000 |
| 00613994533364 | K024278 | 000 |
| 00613994546180 | K024278 | 000 |