The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 6416 Temporary Pacing Lead System.
| Device ID | K042190 |
| 510k Number | K042190 |
| Device Name: | MODEL 6416 TEMPORARY PACING LEAD SYSTEM |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. MAIL STOP T-202 Minneapolis, MN 55432 -3576 |
| Contact | Paula Cordero |
| Correspondent | Paula Cordero MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. MAIL STOP T-202 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 | 2004-08-12 |
| Decision Date | 2004-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169372764 | K042190 | 000 |
| 00643169372757 | K042190 | 000 |
| 00643169372740 | K042190 | 000 |
| 00885074212784 | K042190 | 000 |
| 00885074212777 | K042190 | 000 |
| 00885074212760 | K042190 | 000 |
| 20613994412984 | K042190 | 000 |
| 10885074212804 | K042190 | 000 |
| 10885074212798 | K042190 | 000 |