510(k) K013473 ยท MCW Catheter, Peripheral, Atherectomy
XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL
| Applicant | Xtrak Medical, Inc., Hopkonton MA, US |
| Decision | Substantially Equivalent, Mar 6, 2002 |
| Received | Oct 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013473
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.