The following data is part of a premarket notification filed by Walk Vascular, Llc with the FDA for Clearlumen Ii Peripheral Thrombectomy System.
| Device ID | K163051 |
| 510k Number | K163051 |
| Device Name: | ClearLumen II Peripheral 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 | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-01 |
| Decision Date | 2017-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B139WVSDU01021 | K163051 | 000 |
| B139WV81000 | K163051 | 000 |
| B139WV00081 | K163051 | 000 |
| B139WV00071 | K163051 | 000 |
| B139WV0006011 | K163051 | 000 |
| B139WV0006010 | K163051 | 000 |