The following data is part of a premarket notification filed by Walk Vascular, Llc with the FDA for Clearlumen Ii Thrombectomy System.
| Device ID | K161786 |
| 510k Number | K161786 |
| Device Name: | ClearLumen II Thrombectomy System |
| Classification | Catheter, Embolectomy |
| Applicant | Walk Vascular, LLC 17171 Daimler Street Irvine, CA 92614 |
| Contact | David Look |
| Correspondent | Paul Gasser Paul Gasser 13612 Rushmore Lane Santa Ana, CA 92705 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-29 |
| Decision Date | 2016-10-18 |
| Summary: | summary |