The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Clearpoint System.
| Device ID | K160434 |
| 510k Number | K160434 |
| Device Name: | ClearPoint System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MRI INTERVENTIONS, INC. 5 MUSICK Irvine, CA 92618 |
| Contact | Peter Piferi |
| Correspondent | John J. Smith HOGAN LOVELLS US LLP 555 THIRTEENTH STREET, 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 | 2016-02-16 |
| Decision Date | 2016-03-17 |
| Summary: | summary |