The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Myocardial Lead Implant Tool, Model 10626.
| Device ID | K022238 |
| 510k Number | K022238 |
| Device Name: | MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis, MN 55432 -3576 |
| Contact | Mary Ellen Best |
| Correspondent | Mary Ellen Best MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis, MN 55432 -3576 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-11 |
| Decision Date | 2002-10-09 |
| Summary: | summary |