The following data is part of a premarket notification filed by Mri Interventions, Inc with the FDA for Clearpoint System And Accessories.
| Device ID | K200079 |
| 510k Number | K200079 |
| Device Name: | ClearPoint System And Accessories |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MRI Interventions, Inc 5 Musick Irvine, CA 92618 |
| Contact | Pete Piferi |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteen St. NW Washington, DC 20004 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-14 |
| Decision Date | 2020-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850376007840 | K200079 | 000 |
| 00850359007157 | K200079 | 000 |
| 00850359007386 | K200079 | 000 |
| 00850359007379 | K200079 | 000 |
| 00850359007287 | K200079 | 000 |
| 00850359007270 | K200079 | 000 |
| 00850359007263 | K200079 | 000 |
| 00850359007256 | K200079 | 000 |
| 00850359007249 | K200079 | 000 |
| 00850359007539 | K200079 | 000 |
| 00850359007546 | K200079 | 000 |
| 00850359007621 | K200079 | 000 |
| 00850359007898 | K200079 | 000 |
| 00850359007881 | K200079 | 000 |
| 00850359007829 | K200079 | 000 |
| 00850359007812 | K200079 | 000 |
| 00850359007669 | K200079 | 000 |
| 00850359007652 | K200079 | 000 |
| 00850359007645 | K200079 | 000 |
| 00850359007638 | K200079 | 000 |
| 00850359007232 | K200079 | 000 |