The following data is part of a premarket notification filed by Medtronic Surgical Navigation Technologies with the FDA for Localisa Cardiac Navigation System.
| Device ID | K002869 |
| 510k Number | K002869 |
| Device Name: | LOCALISA CARDIAC NAVIGATION SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 3850 VICTORIA ST. NORTH Shoreview, MN 55126 |
| Contact | Thomas Parker |
| Correspondent | Thomas Parker MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 3850 VICTORIA ST. NORTH Shoreview, MN 55126 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-13 |
| Decision Date | 2001-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169006878 | K002869 | 000 |