The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Detect Surgical Pacing And Mapping Tool.
| Device ID | K040812 |
| 510k Number | K040812 |
| Device Name: | DETECT SURGICAL PACING AND MAPPING TOOL |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | MEDTRONIC VASCULAR 1015 GRAMSIE RD Shoreview, MN 55126 -3082 |
| Contact | Edward Valdez |
| Correspondent | Edward Valdez MEDTRONIC VASCULAR 1015 GRAMSIE RD Shoreview, MN 55126 -3082 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-29 |
| Decision Date | 2004-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994755623 | K040812 | 000 |
| 00613994377890 | K040812 | 000 |