The following data is part of a premarket notification filed by Reverse Medical Corporation with the FDA for Reverse Medical Micro Vascular Plug System.
| Device ID | K150108 |
| 510k Number | K150108 |
| Device Name: | Reverse Medical Micro Vascular Plug System |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | REVERSE MEDICAL CORPORATION 13700 ALTON PARKWAY, SUITE 167 Irvine, CA 92618 |
| Contact | Laura Heaton |
| Correspondent | Laura Heaton REVERSE MEDICAL CORPORATION 13700 ALTON PARKWAY, SUITE 167 Irvine, CA 92618 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-20 |
| Decision Date | 2015-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536027732 | K150108 | 000 |
| 00763000702113 | K150108 | 000 |
| 00763000307806 | K150108 | 000 |
| 00763000307813 | K150108 | 000 |
| 00763000307769 | K150108 | 000 |
| 00763000307776 | K150108 | 000 |
| 00847536020825 | K150108 | 000 |
| 00847536003637 | K150108 | 000 |
| 00847536004009 | K150108 | 000 |
| 00847536020832 | K150108 | 000 |
| 00847536025431 | K150108 | 000 |
| 00763000702106 | K150108 | 000 |