510(k) K223210 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
ClotTriever XL Catheter
| Applicant | Inari Medical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 27, 2023 |
| Received | Oct 17, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223210
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2024 | Inari Medical - Oak Canyon ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011 Open, Classified |
QEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.