The following data is part of a premarket notification filed by Vascular Solutions Inc. with the FDA for Octane Aspiration System.
| Device ID | K173266 |
| 510k Number | K173266 |
| Device Name: | Octane Aspiration System |
| Classification | Catheter, Embolectomy |
| Applicant | Vascular Solutions Inc. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Becky Astrup |
| Correspondent | Becky Astrup Vascular Solutions Inc. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-11 |
| Decision Date | 2017-12-01 |
| Summary: | summary |