The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Visualase Mri-guided Laser Ablation System (sw 3.4).
| Device ID | K211269 |
| 510k Number | K211269 |
| Device Name: | Visualase MRI-Guided Laser Ablation System (SW 3.4) |
| Classification | Neurosurgical Laser With Mr Thermography |
| Applicant | Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Sharon Mcdermott |
| Correspondent | Sharon Mcdermott Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Product Code | ONO |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-27 |
| Decision Date | 2022-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000521462 | K211269 | 000 |