The following data is part of a premarket notification filed by Vetex Medical, Ltd. with the FDA for Revene Thrombectomy Catheter.
| Device ID | K201705 |
| 510k Number | K201705 |
| Device Name: | ReVene Thrombectomy Catheter |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| Applicant | Vetex Medical, Ltd. Business Innovation Center, NUI Galway Newcastle Road Galway, IE |
| Contact | Mark Bruzzi |
| Correspondent | Mark Bruzzi Vetex Medical, Ltd. Business Innovation Center, NUI Galway Newcastle Road Galway, IE |
| Product Code | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2020-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812339030302 | K201705 | 000 |
| 00812339030791 | K201705 | 000 |