The following data is part of a premarket notification filed by Reverse Medical Corporation with the FDA for Reverse Medical Microcatheter.
| Device ID | K122684 |
| 510k Number | K122684 |
| Device Name: | REVERSE MEDICAL MICROCATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | REVERSE MEDICAL CORPORATION 13700 ALTON PARKWAY SUITE 167 Irvine, CA 92618 |
| Contact | Jeffrey Valko |
| Correspondent | Jeffrey Valko REVERSE MEDICAL CORPORATION 13700 ALTON PARKWAY SUITE 167 Irvine, CA 92618 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-31 |
| Decision Date | 2012-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536021945 | K122684 | 000 |
| 00847536003552 | K122684 | 000 |