The following data is part of a premarket notification filed by Walk Vascular, Llc with the FDA for Jeti Aio Peripheral Thrombectomy System.
| Device ID | K201998 |
| 510k Number | K201998 |
| Device Name: | JETi AIO Peripheral Thrombectomy System |
| Classification | Aspiration Thrombectomy Catheter |
| Applicant | Walk Vascular, LLC 17171 Daimler Street Irvine, CA 92614 |
| Contact | David Look |
| Correspondent | Paul Gasser Walk Vascular, LLC 17171 Daimler Street Irvine, CA 92614 |
| Product Code | QEZ |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-20 |
| Decision Date | 2020-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B139WVTUB12 | K201998 | 000 |
| WVSDUP2 | K201998 | 000 |
| B139WVHAND1 | K201998 | 000 |
| B139WVCART2 | K201998 | 000 |
| B139WV1500A2 | K201998 | 000 |
| 08717648351389 | K201998 | 000 |
| 08717648351372 | K201998 | 000 |
| 08717648351365 | K201998 | 000 |