The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Mr Compatible Aspiration Kit.
| Device ID | K181731 |
| 510k Number | K181731 |
| Device Name: | MR Compatible Aspiration Kit |
| Classification | Endoscope, Neurological |
| Applicant | MRI Interventions, Inc. 5 Musick Irvine, CA 92618 |
| Contact | Pete Piferi |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth St. NW Washington, DC 20004 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-29 |
| Decision Date | 2018-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08503590070726 | K181731 | 000 |
| 00850359007683 | K181731 | 000 |
| 00850359007690 | K181731 | 000 |
| 00850359007706 | K181731 | 000 |
| 00850359007713 | K181731 | 000 |
| 00850359007720 | K181731 | 000 |
| 08503590070672 | K181731 | 000 |
| 08503590070689 | K181731 | 000 |
| 08503590070696 | K181731 | 000 |
| 08503590070702 | K181731 | 000 |
| 08503590070719 | K181731 | 000 |
| 00850359007676 | K181731 | 000 |