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 | K141313 |
| 510k Number | K141313 |
| 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 | Jane Metcalf |
| Correspondent | Jane Metcalf 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 | 2014-05-20 |
| Decision Date | 2014-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536004351 | K141313 | 000 |
| 00763000702090 | K141313 | 000 |
| 00763000307783 | K141313 | 000 |
| 00763000307790 | K141313 | 000 |
| 00763000307745 | K141313 | 000 |
| 00763000307752 | K141313 | 000 |
| 00847536003613 | K141313 | 000 |
| 00847536003620 | K141313 | 000 |
| 00847536004344 | K141313 | 000 |
| 00763000702083 | K141313 | 000 |