The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Octane Mechanical Thrombectomy System.
| Device ID | K182232 |
| 510k Number | K182232 |
| Device Name: | Octane Mechanical Thrombectomy System |
| Classification | Catheter, Embolectomy |
| Applicant | Vascular Solutions, Inc. 6401 Sycamore Ct N Maple Grove, MN 55369 |
| Contact | Iroquois Ledbeter |
| Correspondent | Iroquois Ledbeter Vascular Solutions, Inc. 6401 Sycamore Ct N Maple Grove, MN 55369 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-17 |
| Decision Date | 2018-09-11 |
| Summary: | summary |