510(k) K031610 ยท MCW Catheter, Peripheral, Atherectomy
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
| Applicant | Rex Medical, Great Neck NY, US |
| Decision | Substantially Equivalent, May 27, 2003 |
| Received | May 22, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031610
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2004 | Datascope Interventional Products Division ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton. Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.