510(k) K971984 ยท MCW Catheter, Peripheral, Atherectomy
AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)
| Applicant | Microvena Corp., White Bear Lake MN, US |
| Decision | Substantially Equivalent, Sep 19, 1997 |
| Received | May 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971984
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.