The following data is part of a premarket notification filed by Walk Vascular Llc with the FDA for Clearlumen Thrombectomy System.
| Device ID | K120508 |
| 510k Number | K120508 |
| Device Name: | CLEARLUMEN THROMBECTOMY SYSTEM |
| Classification | Catheter, Embolectomy |
| Applicant | WALK VASCULAR LLC 17171 DAIMLER ST Irvine, CA 92614 |
| Contact | David Look |
| Correspondent | David Look WALK VASCULAR LLC 17171 DAIMLER ST Irvine, CA 92614 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2012-11-07 |
| Summary: | summary |