The following data is part of a premarket notification filed by Walk Vascular, Llc with the FDA for Jeti 88 Peripheral Thrombectomy System.
| Device ID | K183403 |
| 510k Number | K183403 |
| Device Name: | JETi 88 Peripheral Thrombectomy System |
| Classification | Aspiration Thrombectomy Catheter |
| 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 | QEZ |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-07 |
| Decision Date | 2019-04-17 |