The following data is part of a premarket notification filed by Walk Vascular, Llc with the FDA for Clearlumen Thrombectomy System.
| Device ID | K140296 |
| 510k Number | K140296 |
| Device Name: | CLEARLUMEN THROMBECTOMY SYSTEM |
| Classification | Catheter, Embolectomy |
| Applicant | WALK VASCULAR, LLC 17171 DAIMLER STREET Irvine, CA 92614 |
| Contact | Brad Culbert |
| Correspondent | Brad Culbert WALK VASCULAR, LLC 17171 DAIMLER STREET Irvine, CA 92614 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-06 |
| Decision Date | 2014-12-02 |
| Summary: | summary |