510(k) K021641 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
XTD THROMBECTOMY CATHETER, XX CM
| Applicant | Xtrak Medical, Inc., Hopkonton MA, US |
| Decision | Substantially Equivalent, Jul 26, 2002 |
| Received | May 20, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021641
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2024 | Mermaid Medical A/S The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spir Open, Classified |
QEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.